Tag Archives: clinical rersearch training in pune

How Clinical Research Management Can Help You?

A scientific analysis manager conducts analysis, investigations and tests of protocol subjects and participants. Their responsibilities consist of collecting data and monitoring the results of the scientific tests. Clinical analysis planners also collaborate with other medical managers in the implementation of scientific tests and the recruitment process of medical trial participants.

Work Experience

To become a scientific analysis manager, applicants for these positions should have prior encounter as scientific analysis experts. Understanding the scientific analysis process and participating in scientific tests are important attributes that companies may need applicants for the job to have. The degree of scientific analysis encounter needed to qualify for a job as a scientific analysis manager is determined by the companies. Some companies may need only one to two years of scientific analysis encounter, while other companies pursue individuals with additional years of encounter.

College Education

Many companies may seek applicants for the scientific analysis manager place who possess an associate’s or bachelor’s degree in scientific analysis. Having a degree in scientific analysis, coupled with less than one to two years of expertise in scientific analysis, may meet adequate minimum qualifications with some companies.

Because scientific analysis planners prioritize and oversee the development and implementation of scientific analysis tests, many companies need them to be licensed as a registered nurse or a licensed practical nurse. Many companies who seek applicants with an RN or LPN license may also need them to have at least one year or more nursing expertise in a medical facility.

Certification

Certification also benefits applicants for scientific analysis manager positions, and some companies need applicants to have a documentation in scientific analysis from approved organizations that offer documentation courses and examinations. The Society of Clinical Research Associates and the Association of Clinical Research Professionals are nationally recognized organizations that offer documentation programs for scientific analysis experts.

Additional Qualifications

Many companies need individuals to be proficient with Microsoft Word, Excel and Outlook. Interpersonal communication skills and encounter working in a team environment are skills needed for this job place. Strong organization and prioritization skills are also beneficial skills that companies may need applicants to possess for the scientific analysis manager place.

Supervisory Role

Many scientific analysis experts become promoted or advance to the higher level supervisory positions after gaining additional qualifications and expertise in scientific analysis. Clinical analysis planners oversee the entire process of scientific analysis investigation and tests and ensure that all medical experiments and tests are compliant with the objectives of each project. Clinical research management is a wonderful field and you can choose to make your career in this field.

Related Posts:

1)6 Ways ResearchKit Would Change Clinical Research

2)Top 10 Clinical Research Interview Questions

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Clinical research for Hair Treatment

Clinical research for Hair Treatment

Treatments for the various forms of losing hairs have on moderate success. Three medicines have proof to back up their use in hair thinning locks loss: finasteride, dutasteride and minoxidil. They generally work better to prevent further losing locks than to replenish lost locks.

They may be used together when losing hairs is progressive or further restoration is desired after 12 several weeks. Other medicines include ketoconazole, and in female androgenic hair loss spironolactone and flutamide. Mixtures of finasteride, minoxidil and ketoconazole are more efficient than individual use.

Finasteride

Finasteride is used to treat hair thinning losing locks. Therapy provides about 30% improvement in losing locks after six several weeks of treatment, and effectiveness only continues as long as the drug is taken. There is no good proof for its use ladies.

It may cause man boobs, male impotence and depression.

Dutasteride

Dutasteride is used off label for hair thinning losing hairs.

Minoxidil

Minoxidil, applied topically, is widely used for the treatments for losing locks. It will work in helping promote growth of hir in both individuals with androgenic hair loss. About 40% of men experience growth of hir after 3–6 several weeks. It is the only topical product that is FDA approved for androgenic losing locks.

Ketoconazole

Ketoconazole may help ladies.

Spironolactone

There is tenative assistance for spironolactone ladies. Due to its feminizing adverse reactions and risk of sterility in men it is not often used in men. It can also cause hypotension, hyperkalemia, and cardiac dysrhythmia. Also, ladies who are expecting or trying to conceive generally cannot use the medication as it is a teratogen, and can cause uncertain genitals in infants.

Flutamide

There is preliminary proof for flutamide in women; however, it is associated with relatively high rates of liver problems. Like spironolactone, it is commonly only used ladies.

Certain hair shampoos and conditioners and creams creatively become thick current locks, without having affected the growth pattern. There have also been improvements in the style industry with wig design. The ornament has also been proven a source of emotional support for females going through radiation treatment, with melanoma heirs in one study explaining their wig as a “constant companion”. Other research in ladies have confirmed a more combined psychosocial effect of hairpiece use.

Specialized head tattoo designs can simulate the overall look of a short buzzed haircut. Clinical research management has always a very good scope and you can make your career in this field.

Related Topics:

1)Requirement of Clinical Research Associate

2)What is the responsibility of a clinical research associate?

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Pain Management Trials With The Placebos

Pain Management Trials With The Placebos

Going by the definition of placebo, it is an inert substance that has no effect on our body. In clinical research, placebos such as sugar pills are used as controls against which the effects of experimental drugs are measured.

Even though the placebo-effect has become a well-recognized phenomenon. A phenomena in which a patient believes he is being administered an actual drug and gradually improves in spite of receiving no active substance.

It also works with surgical procedures. Just like drugs, placebo or sham surgery is shown to produce results that are equal to actual surgery, though the physical problem is not addressed.

Since years, we’ve known about the “placebo effect”—that a patient, simply by believing that a treatment is effective, might experience a beneficial effect from a clinically ineffectual treatment. Of course, it goes against the ethics. The ethics of deceiving patients into falsely believing that a placebo is an effective treatment is questionable—so clinical researchers have recently turned their attention towards open-label placebos.

Random Controlled Study:

OLP vs TAU Group

A recent Pain article documented a randomized controlled study of open-label placebo treatment for chronic lower back pain. 97 patients were divided into 2 groups: One continued treatment as convention (TAU), while the other group received open-label placebo pills (OLP). Before starting with the study, patients were told that the human body can automatically and powerfully respond to taking placebo pills—and all patients were aware of whether they were in the TAU or the OLP group.

At the completion of the study, patients in the OLP group showed significant decline in both pain and disability—in simple words, though they knew that they were on a placebo pill, the patients yet reported an improvement in their chronic lower back pain.

But what does that mean for central nervous system (CNS) clinical trials?

The Essence of Rater Training in Clinical Trials

In this study, the efficiency of the placebo pill can largely be chalked up to the nurturing approach of the rater and investigator, who repeatedly stressed the positive potential of the placebo effect. In CNS trials—especially when it comes to pain management—rater training is absolutely essential to avoid the increasing placebo response rate.

Solution: A Supportive Environment for Treatment

That’s why Clinical Trials employs a four-stage certification process for raters, validating their experience and knowledge and calibrating them to the standard scoring conventions and protocol specific study criteria at the beginning of each study. Raters require knowing that simply being in a therapeutic environment can heighten placebo effect—so a “research” atmosphere, rather than a “therapeutic” one, must be the goal. Interaction with site staff must be controlled, and not unintentionally create a non-specific supportive treatment environment. Staff also must know that they should have no expectations of drug response, either positive or negative, and should explain the same to the patients.

How Rater Training Can Benefit Pain Management Treatments?

To mention, the placebo effect is not a replacement for effective pain-management treatments. By properly training raters to be well aware of the placebo effect and assess each participant in CNS clinical trials, they can very effectively continue the search for treatments for low back pain, osteo-arthritic pain, neuropathic pain and other areas of CNS expertise.

We conclude the discussion here.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will guide you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Why We Need Rigorous Study Designs For Rare Disease Clinical Trials

Why We Need Rigorous Study Designs For Rare Disease Clinical Trials

Finally FDA approved Sarepta’s eteplirsen (Exondys 51), doing this, they actually welcomed the Duchenne muscular dystrophy (DMD0 community. Though it was shrouded with some controversies.

Eteplirsen is a gene therapy drug for administration in DMD patients whose dystrophin mutation is manageable by skipping exon 51.It was approved after a thorough study of 12 patients, 4 of whom, received placebo for 24 weeks before being re-randomized to one of two dosages.There were some brow raising questions regarding the use of historical data as a control in the absence of a concurrent placebo arm of the latter part of the study and the efficacy measures used. But finally, Eteplirsen was given approval by the FDA, and though entire the process was taken over by controversy, demonstrated the power for innovations in designing a clinical trial and analytical methods.

Producing High-Quality Data

After this recent approval, and the essentials for novel clinical research in rare drug development, it might be tempting for sponsors to push boundaries such that their drugs comes to market more fast and at cheaper price. The authorities of Food and Drugs says that owing to all controversies over Eteplirsen they must multiply their efforts to propagate the therapeutic development ecosystem to apply methods that would yield high-quality data from the beginning.

Requirements for FDA Approval

There are certain criteria that need to be fulfilled to get FDA approval. This needs evidence of efficacy and clinical utility of a candidate with well accepted standards and research trial design should portray those needs. Considerable flexibility in evidentiary standards of approval has been noted by other authors in the orphan disease space, suggesting a portfolio of design options that might be possible contingent upon the nature of the product and the therapeutic target. Like other therapeutic areas, endpoints must be clearly defined and time points should be clinically practical. Although the use of historical controls can be considered as a component of the review process (like in cancer drug development), patients must be exactly matched and clinical assessments must be standardized across all contributing trial centres.  Statistics must be prospectively designed to account for all time points and dosages, and potential heterogeneity across reference trials.  Studies should be planned such that the protocol is elaborate with the endpoints; in simple words, test what you have specified.

Bringing Innovation to Trial Designs

Many ways novel ideas can be introduced to planning trials while maintaining the standards of scientific excellence.  When you have to design clinical trials for rare disease, this might include getting the most out of early phase studies.  If your access to patients is limited, make sure that every patient enrolled in the study “counts” – that even proof of concept studies are well designed and properly optimized to help lend credence to later phase studies.  Innovation can also be introduced in study design, mainly in early phase research, that mixes endpoints to reduce timelines and streamline outcomes while informing the next stages of drug development.  A classic instance of this is the mixed SAD/MAD studies that includes algorithm or model based methods of dosage escalation for the purposes of defining an operational dose range for subsequent studies.  To include, Worldwide Clinical Trials has been able to use creative designing to shorten the timelines by 4 months.

We conclude the discussion here.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider excelling yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will help and guide you in making a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Top Hurdles For Patient Participation in Clinical Trials

Top Hurdles For Patient Participation in Clinical Trials

Today we dedicate our blog topic to the hurdles that is face during participation of patients as part of clinical research.

Huge amount of money and good amount of time is spent in enrolling patients and hence addressing the concern of the hurdles that is faced must be addressed to increase study chances and reduce failure rates.

So while designing your trial, keep these 4 barriers in mind as an attempt to prevent participant dropout and errors before they become a threat for the success of your trials:

1 Misconception:

To a patient, the clinical trial phases are full of unknowns. The patients should be detailed about the processes otherwise they might be concerned by fear of being a “guinea pig”, odds about placebo, loss of autonomy, or worries about unknown side effects.

Solution:

You need to address these concerns very early during interactions with the participant. Communicate well how each aspect of the trial is important. You should also mention the advantages of participation, like gaining access to expert medical care, knowing more about their condition, and being active players in their own health care.

2 Mistrust:

Try to understand that history saw mistrust in the medical field, mainly when dealing with minor populations.

Solution:

Be transparent with the patient about your actions and this would be helpful because it will identify and explain the study motives. Another way is that you break down if any communication barriers like language or technological literacy.

3 Logistics:

When developing and implementing a clinical trial, be practical with various aspects. In addition to achieve heights for your site staff, ensure to evaluate the trial design from the participant’s view point, like they must have a busy life and they must be considering your trial a priority in their lives. Common logistical hurdles include inability to take leave from work, transportation to and from the research site, how often they need to be present and how far they might need to travel. Whether they have kids or rely on caregivers, this factor can make things complicate in their participation.

Solution:

During the design of your trial, be mindful about what is needed of the participant. Know the barriers and try to address them as much as possible.

4 Costs:

In order to overcome logistical barriers, many patients will spend their own money to participate in a clinical trial. If your participants face delays in the payment process, they might be forced to wait for reimbursement for up to weeks at a time. With this prolonged and slow payment model, participants might be on their next trial visit before being paid for their last visit. This delay might leave the subject feeling undervalued or that the trial is not systematic, which could lead to decline in compliance and participation.

Solution:

As the participants need a variety of accommodations for logistical planning, they might also need a diverse payment options. Giving your subjects a choice on how they would like to be paid increases your site’s dedication to patient’s concern, which increases the chances of a positive experience in clinical trial. Tools like Nimblify’s Participant Payments provide a variety of payment options that could not only decrease your site’s administrative burden, but also offers other effective and diverse payment plans for participants.

Reducing these barriers to participation in a clinical trial can lead to more reliable study data, make your site more patient-centric and provide an overall better participant experience you achieve future success.

We conclude now with this discussion.

Please let us know your opinion and views on EDC and its usage in CDM in the comment section below.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will guide you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Clinical Research Industry’s Strategy to Epidemics

Clinical Research Industry’s Strategy to Epidemics

In the field of clinical research mainly epidemic response face many challenges. Clinical research done on global health concerns often needs rapid action, immediate trial start-up and lower standard good clinical practice (GCP), among many other struggles. It’s very difficult to carry out a clinical trial during the course of an epidemic. However, there are measures to overcome these challenges.

In a recent conference of Partnerships in Clinical Trials (PCT) that was held as a part of Boston Biotech Week (BWB), two inspiring presenters shared their story of journeys working to combat infectious diseases, like Ebola and Zika, in 3rd world countries. Both the presenters presented a common idea that the research industry needs to work together to become more prepared for responding an epidemic occurrence of an outbreak.

Collection of right data

Presenter Toni Hoover of Bill & Melinda Gates Foundation said on the power of technology and therapeutic innovations to fight diseases that affects underprivileged individuals. She said that their organization is dedicated to enhancing quality of life worldwide, works with many people to give vaccines and new therapies to people in poor and downtroden communities.

The Foundation and its collaborators in the biotech field are working to collect data required to make informed decisions during an epidemic. Hoover said that the data has the potential to be utilised to predict where the next epidemic might occur, pronouncing that the whole healthcare ecosystem needs to work together to prepare and develop a platform for combatting with epidemics like that of Ebola and Zika. She said that Zika is a perfect example that says the need to think about interventions, but also how preparations can be made with the help of collection of the right data to advice decisions.

Industry transparency must be increased

In the same manner, presenter Trudie Lang of the Global Health Network at the University of Oxford expressed her belief that the clinical research industry must be more prepared to respond in the event of an outbreak.

With reference, Lang shared her experience as a researcher performing an Ebola trial in West Africa. She described the hurry to begin the study and was under immense pressure to complete the trial in 16 week only. Lang said that her team was able to complete the clinical trial at rapid speed, but admitted they were too late. The epidemic already spread fast by the time the trial was complete.

This experience made Lang realise that the research community must be always ready to combat infectious diseases before an epidemic reaches a downward slope, more possibly before an outbreak occurs.

Finally Lang proposed a solution to the current problem by saying that research information must be shared and there should be transparency in clinical research industry.Lang came forward with an argument that sharing clinical research information between groups, plagued areas and regions would enhance the agility of a research enabling faster response to life-threatening diseases.

Fact is that epidemics and global diseases are significan cases for the need of organizational collaboration and information sharing. The two women and their research highlighted many aspects of clinical research that could prevent or help people in their suffering worldwide.

Now we conclude the discussion.

To learn more methods for increased industry efficiency, view our library of resources for clinical research professionals.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in offering the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current requirement of the proficient candidates, you should consider enhancing yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will help and support you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Interview For Pharma Freshers : Tips & Preparations Part II

Interview For Pharma Freshers : Tips & Preparations Part II

Today we continue with the same topic we were discussing in our previous blog post.

Interview tips

The three aspects of the interview process:

  • Pre-Interview Planning
  • Interviewing
  • Following-up

PRE-INTERVIEW PLANNING

This will make you more confident and keep you motivated. Before you start keep a written or computerized list:

  • Date resume was sent
  • Name of company
  • Name of person you sent it to
  • Address
  • Phone
  • Date and time of interview
  • Results of interview
  • Second interview
  • When you sent a thank you letter or note

You need to find about the company thoroughly, which is very essential but it is often neglected. Try finding out the following information:

  • Products or services
  • Company history
  • Number of employees
  • Business methods
  • Distribution methods
  • Organizational structure
  • Clients or customers -Locations
  • Reputation
  • Philosophy
  • Industry standing/ Sales or activity volume
  • Prospects for company growth

INTERVIEWING

You need to relax and think about all of your skills, accomplishments, and abilities. You should know your strength and weakness. You need to make a resume that would say everything about in details and must be appealing.

Resume

  • Be honest.
  • You need to quantify your achievements with figures and percentages
  • You must think in terms of increasing productivity, decreasing costs, and increasing profit for the company.
  • Try to appear relaxed and alert
  • Be friendly and an enthusiast.
  • Always dress in your formals and be calm in your look.
  • First impressions counts.
  • Groom yourself well.
  • Sit comfortably and with good poise.
  • Ask questions. If you want to clarity certain aspects of the job.
  • Don;’t ask about paid holidays and vacations unless the job is offered
  • Carry extra resumes and references with you.
  • No fancy jewelry please.
  • Be polite.
  • Show a can-do and positive attitude.
  • If asked general questions, answer in terms of your professional abilities and experiences.
  • Never, never criticise former employers.
  • Have good posture and direct eye contact.
  • Give a firm handshake before and after the interview
  • Speak clearly in a firm, confident, and not too loud voice
  • Smile, when appropriate
  • Try to relax
  • Give specific answers to all questions. Don’t be vague.
  • Thanks the interviewer.
  • If you are really keen for the job, tell the interviewer again before you take your leave.

EMPLOYERS INDICATE THAT YOU CAN HURT YOUR CHANCES OF GETTTNG A JOB BY :

  • Poor career plans
  • Under qualified for the position
  • Communication not proper
  • Unsatisfactory evidences of achievement
  • Fail to research the company
  • Displaying a lack of interest in the organization
  • Unwillingness to relocate
  • Appearing more interested in money and benefits than anything else
  • Fail to follow-up post interview

THE GOLDEN RULE OF INTERVIEWING:

Be yourself, know yourself, and sell yourself.

Employers are looking for someone who can contribute to the buisiness by:

  1. Making Money
  2. Saving Money
  3. Saving Time

So keep it in mind.

WE conclude the discussion now. You have to prepare by your own and crack your interview confidently.The above tips are very essential to keep in mind. Good luck!

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider improving yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will help and guide you in making a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

A Dilemma For Big Pharma Companies : CNS Drugs

A dilemma for big pharma companies : CNS Drugs

The central nervous system (CNS) is the most complicated area of clinical research. And currently the big pharma companies are keen to invest in this therapeutic area. But the R&D spends have not yet got rewarded with the desired results. R&D in this area is risky and chances of approving the drugs by the regulatory board are very slim. Hence big pharma companies are at the risk of major losses.

The budget of clinical research for developing a CNS drug versus a cardiovascular drug is 30 percent higher and the chances of a CNS drug reaching a great status in the market is about 50 percent lower.

Research and development by big pharma companies in area of diseases like depression, anxiety, schizophrenia, Alzheimer’s, Parkinson’s and stroke have invited the risks of heavy investments but very less guarantee of success.

The big companies concluded that the risks associated with CNS drug development are very high—so are they justified?

Challenges Facing CNS Drug Development

External pressures have created trouble for the pharma industry’s efforts to address CNS disorders like the active “anti-psychiatry” movement made up of organisations, politicians, religious groups and layman who does not believe the importance of psychiatric treatment.

Moreover there are also the internal pressures. For instance only 8.2% of CNS drug candidates become available for clinical use, compared with 15% of other drugs. Phase II and III of clinical trials and also the regulatory approval; all takes much longer for CNS drugs compared to other therapeutic drugs. Some CNS drugs might take 18 long years from preclinical work to marketing, and clinical research organizations rarely take the benefits of available regulatory tools like Priority Review and Fast Track designation.

Phase III failures

As per reports, most CNS R&D losses of recent years are due to the fact that the majority (4 out of 5) of CNS leads fail the most crucial and expensive phase III stage of clinical trials. And reasons are numerous that includes strict board regulations for CNS disorders to insufficient understanding of the facts underlying brain disease.

What Clinical Research Organizations (CROs) Can Do?

To mention, the figures say that CNS disorder – patients outnumber that cardiovascular disorders ones and with increase in population, the numbers with CNS disorders are increasing. To address this need, there are some ways to enhance the speed of CNS drug development like; implementing proof-of-concept studies, orchestrating studies with a singular drug development team rather than by handing off studies phase by phase, and embracing open, dose-ranging trials followed by moves to a small sample, randomized clinical trial before the move to Phase III. The idea to co-develop CNS drugs with publically sponsored research institutions can also lessen the known risks involved in the development process of CNS drug.

Effective CNS drugs can lessen patient suffering, prolong longevity, improve life-quality and address public health concerns—so it’s essential for all of involved in the drug development process of CNS to look for innovative approaches in bringing these drugs from lab to the market.

We conclude here.

The fact is that disorder associated with central nervous system need to be seriously considered and effective measures in their development process should be initiated.

Amidst many organizations providing clinical research training, CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing yourself with CRB’s clinical research training program.

The Clinical Research review by CRB Tech Solutions will guide you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

Myths and Reality Of EDCS In Clinical Data Management

Myths and Reality Of EDCS In Clinical Data Management

Today in this blog topic we would discuss EDCS and its utility in CDM i.e. Clinical Data Management. EDCS is the acronym for Electronic data capture System.

EDC is very common in usage in clinical study yet there are so many myths and misconceptions surrounding the move from conventional, paper-based clinical data input to EDC. The only fact is that EDC technology more the cloud-based systems are comparatively a recent addition to the clinical research industry.

Though EDC is no longer a novel object, yet it is too young to be embraced as the next industry standard. EDC is caught somewhere in between.

Here we discuss the myths surrounding with it and how to overcome them.

Myth 1: EDC is expensive

Reality: EDC cuts down study costs

Some EDCS are pricey to install, train the staff and implement, but the overall budget during the study and after the study cannot be underlined. Sponsor ROI for switching to EDC is well worth the initial investment.

The very thought that EDC is expensive is a remnant of the early history of EDC. When the technology was first initiated, as with any first generation thing, the more capable the system was the more expensive it was. EDC vendors are now available, all competing to overtake in performance the other guys and that too in the most attractive price point.

Myth 2: Switching to EDC involves too much time

Reality: EDC is very precious to study time

This myth has been true when EDC got first rolled out for clinical trials, but it is entirely a baseless argument today. To mention, 80% of the time and money spent on pharma development is spent on repetitively conducting clinical trials. For your information, EDC allows both for an attractive cost ROI and time ROI too.

On an average, EDC cuts 41% of pre-study preparation time.

Myth 3: Data stored in the cloud is unsafe

Reality: Cloud storage is comparatively more secure than on-site and/or paper

We all know and heard about the urban style of cyber theft. We hear horror stories of identity theft, hacking of bank accounts, etc. Always an exception exists for the rule; data storage for the most of of cloud systems is protected with huge and redundant security protocols against loss, theft or corruption of integrity. 

Myth 4: EDC is meant for massive Phase III+ studies

Reality: Studies of every size can take advantage of EDC

Though the origin or initiation of EDC was done keeping larger studies in mind like phase 3 clinical trials or later, but currently there are systems present to match every varying degree of study be it simple ones or complex. Of course, the longer the duration and greater the number of variables measured will explain the actual value of switching to EDC.

To mention EDC systems are very much customizable. If your next clinical venture is going to have more or less data than the previous study, your EDC vendor can work with you to customize the system as per requirement, so your team does not need to spend time and effort to source another vendor.

What are the possible disadvantages of EDC for CDM?

To be honest, there is not a single scenario where EDC does not defeat or is a better choice than paper-based data management in terms of savings of time and money. EDC is even “green” compared to conventional data capture methods.

We conclude.

Please let us know your opinion and views on EDC and its usage in CDM in the comment section below.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current demand of the proficient candidates, you should consider enhancing yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will guide you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter

How To Get The Right Patient In Making A Decision

How To Get The Right Patient In Making A Decision

With the rise of clinical trials all over the world, there is an increased involvement of patients in medical discussions, a very welcoming policy or methodology. They have rights, not only since they are the ultimate customers but they are every essential to the entire process. Their views can help in the regulatory process, with its raising sacle of interactions like patient representatives in some of its scientific assessment of individual products.

It is a two-way path, too. For every soul concerned in healthcare sector, an informed patient can help and support make care more effective, with improved support, more developed relations with respective physicians, and wider broader understanding of the challenges of drug designing and regulation.

But this two-way path can also prove to be dangerous. Patient’s opinions and demands might not always share the logic of the process that produces their products. It is quite reasonable to seek passenger’s views on the attribute of aircraft seats, but they have quite less to contribute on airframe design or navigation. In similar ways, not every view of every patient is could be helpful in determining the most appropriate scientific, clinical or commercial approach to medicines. An wrongly informed patient can make a doctor’s life pathetic.

So how can you strike the right balance into customer links and decision-making on remedies? A European project that began at the end of October is aiming to take over this hurdle. The final outcome would be suggestions to support developing guidelines for industry and health technology assessment authorities. In simple words when and how should decision makers give an ear to the patients?

The project, sponsored by EU’s joint-venture in drug research, would mainly concentrate on three disease areas where patient and clinical trial partners have expertise: neuromuscular disorders, rheumatoid arthritis and cancer.

According to Ulrik Kihlbom, one of the Swedish academics involved in the above mentioned project, the challenge is very real and needs a thorough discussion among a wide range of partners. How could a settlement authority weigh the patient perspective against cost-effectiveness when making a repayment of money decision, he reviews? Or how does a regulatory authority weigh patient need contrary to safety matters? Patient’s views need to represent the actual opinions patients have, and be unbiased. And for the individual customer, at what point should his or her voice be listened to? When his or her first diagnosis occurred, or when was under treatment? It is recommended that the patient’s choice will definitely change during the occurrence of illness. Is it to know when your choice is such that your physician must listen to them?

At this present time in Europe, patients’ voices are being increasingly given attention on concerns as wide as access to social and health care, availability of medicines, assessment of health technology and the shaping of broad health policy, the preferable initiative is quite in time. The very question, however, is whether Europe can wait for more years for its recommendations, as “patient potential” is already coming up very strongly, whether it is “correct” or wrong.

In the competition of many other organizations, CRB Tech Solutions earned a good name. It has earned a niche in providing the best training in Clinical Research.

With increasing Clinical research   there is an immense need to meet the current requirement of the efficient candidates, you must consider improving yourself with our clinical research training program.

The Clinical Research review by CRB Tech Solutions will help and support you in considering a clinical research career in this field.

Don't be shellfish...Digg thisEmail this to someoneShare on FacebookShare on Google+Buffer this pagePin on PinterestShare on LinkedInShare on RedditPrint this pageShare on StumbleUponShare on TumblrTweet about this on Twitter