Monthly Archives: September 2016

Is Clinical Trial A Product Or A Service?

Is Clinical Trial A Product Or A Service? in a recent ACT ‘What do you think?’ survey, readers were asked if a clinical trial is a service or a product. Only 53% of people identified a clinical trial as a service. Other responses included product (7%), neither (20%), or other (20%) with the most common response in the other category being ‘research.’

These responses are quite typical. There is a lot of confusion within the industry about what the value developed by clinical trials – even till the point of knowing whether a clinical trial is a product or service. This confusion degrades value creation, productivity.
Clinical trials are done to collect data regarding the safety and efficacy of new drug and device designinh. There are many steps and stages of approval in the clinical trials process before a drug or device is out in the consumer market.

Drug and device testing starts with laboratory research which can involve years of experiments in animals and human cells. If the initial lab research is successful, researches send data to the FDA for approval to continue research and testing in humans.

Once getting the approveal, human testing of novel drugs and devices can start and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of the phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.

Reasons for Conducting Clinical Studies

Basically clinical studies are designed to add to medical knowledge related to the diagnosis, treatment and prevention of diseases or conditions. Some common reasons for conducting clinical studies are:

  • Assessing one or more interventions for treating a disease, syndrome, or condition
  • Finding ways to avoid the initial development or repearation of a disease or condition. These can include medicines, vaccines, or changed in lifestyle , among other approaches.
  • Assessing one or more interventions aimed at identifying or diagnosing a particular disease or condition
  • Examine methods for identifying a condition or the risk factors for that condition
  • Finding and measuring ways to enhance the comfort and quality of life through supportive care for people with a chronic illness

A clinical trial is a service, as the application of knowledge and skills to benefit another entity. The keyfeatures of services are that they involve delivery processes. Products are goods manufactured basically in a yield setting. It is much easier to measure and organise the yield process of products. Service processes are much more difficult to measure and manage.

This doubt about whether a clinical trial is a service or product also results to lower-quality clinical trials and billions of dollars wasted on ineffectual quality improvement investments. Yet, the industry measures trial quality as if it is a product – leading to mismanagement and low-quality trials. The industry has spent billions of dollars trying to improve the quality of trials in the past years without any improvement in reality. The basic reason is that the industry still hasn’t figured out if a clinical trial is a peoduct or a service .

In the race of many institutes CRB Tech Solutions has created its own place. Its known in offering the best training program in Clinical Research. Our clinical research institutes has created a niche for itself in this field.

Clinical research jobs are gaining grounds gradually and to meet the emerging need of good professionals , you should consider upgrading yourself with clinical courses.

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

Related Posts:

1) Why Clinical Trials Are Very Much Useful Through Mobiles?

2) Clinical Trials and Its 4 Stages for New Medications

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Apple Plans Transform HealthKit From Tracker To Diagnosis Tool

Apple Plans Transform HealthKit From Tracker to Diagnosis Tool

Till date Apple’s HealthKit has mostly collected fitness data from its devices. In the future, if the company finds its way, the software will interpret that information, converting it into advice for users, doctors and others.

Many health care experts hired by Apple in recent years are designing enhanced electronic health record software that can well analyze and understand the implications of patient data.

The iPhone manufacturer is even working on new apps for the Apple Watch. It can track users’ sleep patterns. Another app focusses on fitness levels by calculating the time taken for the heart rate to fall from its peak to resting level. Apple already has an app that measures heart rate, but yet don’t interpret them.

The ultimate goal of Apple’s health care technology team is to turn HealthKit into a tool that improves diagnoses. The system could do away two problems that plague the field of clinical research and have stumped other specialist firms in the field.

Chief Executive Officer Tim Cook wants Apple to act more in improving software and services to secure new sources of economy and make customers more dependent on the company’s devices.

In early this year, Apple bought Gliimpse Inc., a startup that build software to pull electronic health records from different databases and in different formats and finally store them in one place.

He equated the product to Apple’s music business. That negan with the iPod, but as more people became habituated to storing all their music files digitally, Apple united all music lovers in a single platform on top of the device.

Apple health software might become a revenue driver, too, by keeping people intrigued to the company’s equipments. If a patient’s health records, and related suggestions, are reachable through Apple’s system, it would be difficult to trade in an iPhone for a smartphone running Google’s Android OS, and its health-tracking software Google Fit.

The second module of Apple’s Watch has a built-in GPS tracker, faster processor and is water resistant and many people can run, swim and do other exercise with the device. The upgraded Watch software, dubbed watchOS 3, puts health tracking information more prominently in the user interface, and adds a breathing during exercise app as well as tracking during swimming.

Building more sensors into the Watch serves a limited purpose. The accelerometer can generate most of the useful data needed to monitor a person’s well-being. A glucometer or blood-pressure sensor would only help a small percentage of users, the person said.

Scott Jenkins, said that Apple is working hard with many of these large institutions to produce tools that are medically significant, to take data from sensors.

Stephen Friend, a Merck & Co. veteran who founded health data non-profit Sage Bionetworks, is honored with being the brains behind ResearchKit. He joined Apple as full-time employee in June after working as a consultant for more than two years.

Yoky Matsuoka, formerly technology chief at Google’s Nest Labs unit, joined Apple’s health team last year. Nest mostly known as a hardware specialist, but Matsuoka head the development of software that interpreted and learned from data that its internet-connected thermostats collect.

Apple’s greatest obstacle for now is proving to medical professionals that data delivered from wearables through HealthKit and ResearchKit is reliable.

In the competition of many organizations CRB Tech Solutions developed a big name. Its better known in providing the best training in Clinical Research.

Clinical research jobs are increasing and to meet the increasing requirement of the peofecient professionals , you should consider improving 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.

Related Topics:

1) Top 10 Clinical Research Companies in Pune

2) Clinical Research Organization

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Impact of GST on Pharma Industry

Impact of GST on Pharma Industry 

The news is that finally the long-awaited Goods and Service Tax Bill (GST Bill ) has overcome the hurdles of both the houses in parliament. A turning point it is for the country because it will not only make the method of taxation easy to understand but also lessen the malpractices that have been prevalent due to obscurity and confusion of tax norms.

The GST regime is supposed to bring a great boost to the pharma industry by making the supply chain management efficient and lessening the cost of manufacturing pharmaceutical products. The reduction in the costs will be of added value to the profit margins which is a good thing for the manufacturers.

As the bill has gone through various rounds of discussions and it was under consideration for more than two years, it is obvious that it has come out as the well planned bill and now the government is determined to make it a success by taking all the necessary ways. Now the constitutional difficulties are issue of the past, and the corporate world is gearing for understanding the possible effect of GST on the business.

What all will be included in GST?

Though the basic objective of implementing GST is to about eliminate the long list of taxes and levies. It is a route towards easy and manageable tax liabilities. GST is expected to lessen following tax burdens at the state and central levels.

Central level taxes

Service tax,countervailing duty, central excise duty, additional excise duties, special additional duties of customs, and excise duties under the medicinal and toilet preparations Act of 1955 will get abolished by the new system. Also, extra charges on the supply of services and goods will also get removed.

State level taxes

CST, Entry tax, purchase tax , sales Tax and VT at the state level,luxury tax, State level entertainment tax, taxes on lottery and gamble will be included under the GST head. Also, surcharges on the supply of goods and services at the state level will also get abolished.

Specific impact on the pharma industry :

  • Under current system, specific API or life-saving drugs has the benefit of non-levy of excise duty if they are included under some specific notification of the Central Excise Law. Now the Central Excise Duty will get merged in GST, and hese life-saving drugs will gain the Tax-Free status. The previous goods will also enjoy exemption from IGST in case they are imported.
  • Even it will be quite interesting to know about the translation of the collection of credits when GST is applicable. Since pharma companies give a high stack into it, the impact will be wholesome.
  • In the existing model of Indirect Tax law, supplies made to a loan licensee enjoy exemption from VAT. It is important that the industrialists get the clarity about the situation post-GST implementation. Also, currently there is no service tax on the processing charge paid to the loan licensee because the process comes under “manufacturing process”.
  • Though the proposed bill says that the existing advantages will be continued, it is very much crucial that business owners make the situation clear.

In the race of many organizations CRB Tech Solutions has created a big name. Its well known in offering the best training in Clinical Research.

Clinical research jobs are rapidly increasing and to meet the increasing demand of efficient professionals , you should consider optimizing yourself with our clinical research institute.

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

Related Topics:

1) Top 10 Clinical Research Companies in Pune

2) Clinical Research Organization

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Digital Health

With digitalization is its development, the field of clinical research introduces a new word to the list. Yes we are talking about Digital health which is the way by which digital and genomic revolutions converging with healthcare and society. Digital health is enabling people to a better track and improve their own and family’s health, live a better life, more productive lives and improve the society.

Now what is the scope of digital health? It has a broad scope that includes health information technology (IT), mobile health (mHealth), wearable devices, telemedicine and telehealth and also personalized medicine.

Other usage of digital health in their efforts to:

  • Lessen inefficiencies,
  • Enhance access,
  • Lessen costs,
  • Improve quality,
  • Make personalized medicine for patients.

Patients and consumers can use digital health to manage and keep a track of their health and wellness related activities.

The use of technologies such as social networks, smart phones and internet applications is not only changing the way we communicate, but is also providing novel ways for us to supervise our health and well-being and giving us greater access to information.

Why is FDA focusing on Digital Health?

Many medical devices now have the ability to connect to and communicate with other systems or devices . FDA approved devices are are being updated to add digital features. New devices that already have these capabilities are now explored.

Many stakeholders are involved in digital health activities, including patients, researchers, health care practitioners, conventional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.

FDA’s Center for Devices and Radiological Health is overwhelmed about these developments and the combining of medical devices with connectivity and consumer technology. The following are the topics in the field of digital health on which the FDA has been working to provide clarity using practical approaches that balance benefits and risks:

  • Mobile medical apps
  • Wireless Medical Devices
  • Health IT
  • Telemedicine
  • Medical Device Data Systems
  • Medical device Interoperability
  • Software as a Medical Device (SaMD)
  • General Wellness
  • Cybersecurity

How is the FDA developing Digital Health?

CDRH has established the Digital Health Program which tends to protect and promote public health and provide continuous regulatory clarity by:

  • Encouraging collaborations and increasing outreach to digital health customers.
  • Creating and implementing strategies and policies for digital health technologies.

Federal Trade Commission Mobile Health Apps Interactive Tool

If you are designing a mobile health app that collects, creates, or shares consumer information, click on the button to take you to the tool on Federal Trade Commission’s website to find out when FDA, FTC or Office of Civil Rights (OCR) laws apply:

Genomics and Genetics

According to J. Craig Venter, digital health is basically a DNA-driven software device and there is no difference between digital code and genetic code. Digital code is a binary code: 0, 1. while, genetic code is a four-base code: A, C, G, T. There can be no conversion between the two as well as digitized man, as Topol defines it in expanded terms.

Stay connected for more exciting blogs and articles and increase your knowledge with us.

Are you looking for Clinical research course in Pune, then our CRB Tech Solutions would provide with help and support. Its very popular in offering the best training in Clinical Research.

Clinical research jobs are pacing and to meet the emerging need of efficient professionals , you should consider upskill yourself with our institute of clinical research.

Clinical Research review by CRB Tech Solutions can help you in considering a clinical research career in this field.

1)5 Ways ResearchKit Is Revolutionizing Clinical Research

2)Crowd funding In Clinical Research

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Rise In Mercury Brings Down Swine Flu Cases

Rise In Mercury Brings Down Swine Flu Cases With the soaring temperatures, swine flu cases which makes people in majority vulnerable seem to have subsided. Only a few patients are tested positive for the H1N1 virus out of total patients who took admission in hospitals.

Dr Charan Singh, nodal officer for swine flu in the Health department in the capital, said that every year, with a rise in temperatures, the virus tends to recede. Hence there are fewer cases now. Cases would have come down more but owing to the unseasonal rains, some cases yet exist.

As per reports of 2015, since January 1st , 4,266 patients tested positive for the virus in Delhi with 1,500 being reported in the month of March. There are reports of twelve deaths from the capital, including two pregnant women and one child.

Health officials told that required arrangements for swine flu, including treatment and diagnostic facilities, will be kept functional till the cases subside completely. Isolation wards remain closed from April-May, but that time it was kept open. An official reported that doctors are expected to continue with treatment guidelines of category A, B and C patients. The nodal officer said that in most of the cases, patients have been suffering from conditions mainly diabetes, heart and respiratory diseases.

As reports of an official from the Union Health Ministry, the year 2015 also saw majority number of deaths and huge number of cases as per reports in the last 6-7 years. It claimed the lives of approximately 2,200 people and affected another 35,000. While 981 deaths were reported along with 27,236 cases of swine flu in 2009, the disease claimed the lives of 1,763 people in 2010 and affected around 21,000 people. In 2011, 603 cases were reported and swine flu claimed 75 lives while, in 2012 there were 5,045 cases and 405 deaths. Swine flu claimed 699 lives and affected 5,254 people in 2013. In 2014, 938 cases were reported and 218 deaths were caused by the virus.

With advise to the people, Singh said them not to “panic”. He continued ro state that H1N1 is a self-limiting disease and if treated in the early stages, chances of complications are quite less. There are no reasons to panic as most of the cases reported are of seasonal common cold or flu. He added that people should simply maintain routine hygiene. The Health department authorised the private hospitals with more than 50 beds and equipped with ventilators to treat swine flu patients. The new guidelines have included 122 private hospitals to treat H1N1 patients, along with 19 government and seven private ones that was previously designated as authorized centers.

The fact is that as soaring temperature reduce swine flu incidence; rains increase it. The unseasonal spell of rain has come as a dampener for the district officials of health department who were hoping that cases of swine flu would lessen with a rise in temperature. The rains have caused drop in temperature making it favorable for the virus to spread.

Well its clear that the only way the incidence of swine flu remains suppressed is higher temperatures and rains can worsen the conditions.

In the race of many institutes CRB Tech Solutions has developed a niche. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a place for itself in this field.

Clinical research jobs are increasing rapidly and to meet the increasing need of efficient people , you should consider upgrading with clinical courses.

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

Related Posts:

1) Stem Cells Therapy- A Hope For  Parkinson’s Cure

2) Clinical Research for Pulsing in Veins

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Stem Cells Therapy- A Hope For Parkinson’s Cure

Parkinsosn’s disease affects the middle aged people and what to be known is that exercise in middle age can prevent the occurrence. Many clinical trials are being carried out to find a definite cure to the condition. One among them is stem cells therapy which seems very promising.

In this blog we narrate the ordeal of a 59 year old man who lived with Parkinson’s disease(PD) for 12 years. Ashok Kumar formerly served as a general manager in a private firm, had been leaving an active and productive life until he was diagnosed with PD. This progressive neurological disorder brought his life to a halt and then followed years of futile treatment and he started losing hope. But then his decision of undergoing stem cell therapy for PD turned out to be one of the most favorable decisions of his life.

Talking about his dilemma , Kumar said that he couldn’t stand, sit or walk. He would fall forward and his body suffered from tremors, postural instability and rigidity. When he was at the verge of giving up his hope of recovery, then Plexus Neuro and Stem Cell Research Centre reignited new hope in his life. The stem cell therapy was initiated and within four months his speech, posture, writing ability and body balance improved a lot and he no longer had to take any medications for PD.

Dr Naeem Sadiq, neurologist and director of Plexus Neuro and Stem Cell Research Centre said Kumar is one of the many Parkinson’s patients who have got successfully treated at the center. They have 25 years of clinical experience in treating neurological disorders and provides stem cell therapy for neurological, orthopaedic and psychiatric disorders and several other incurable diseases.

In the early times, medications and certain surgical procedures were the only treatments available for PD. Though medications is less effective in the long-term and might cause side-effects, surgery is not always feasible or goos choice.

In recent years, application of stem cell therapy for treating PD has become a boon for the patients. Stem cells are like mother cells which originate from the developing embryo and differentiate into different types of cells. They are also named progenitor cells as they create new cells. Dr Sadiq said that in stem cell therapy for Parkinson’s disease, stem cells are collected from the patient’s own bone marrow. The cells are isolated and after lab quality analysis, the isolated stem cells are transplanted into the patient’s body. The stem cells migrate to the affected area of the brain, get attached there and transform themselves into healthy tissue and hence replace the damaged cells.

After this procedure the patient is discharged the next day. Regular follow-ups are important and based on the severity of disease, a patient might need subsequent doses of stem cell transplant. In case of Kumar, two doses of stem cell transplant in four months period worked effectively said Dr Sadiq.

Later stages of Parkinson’s are highly debilitating. With the progress of the disease, dopamine producing brain cells get lost in the substantia nigra region of the brain. Dopamine, a brain chemical that plays key role in regulating coordination and movement of the body. Till date, the exact reason behind the loss of dopamine cells in PD is not well clear.

Early detection and timely treatment of PD is crucial for positive treatment outcomes. The general public lacks awareness of PD. The initial stage of PD usually begins as mild tremors on one side of the body which is either neglected by patients or misdiagnosed.

If you are looking for Clinical research course in Pune, then CRB Tech Solutions would provide with proper guidance. Its one of the best in offering training in Clinical Research.

Clinical research jobs are increasing fast and to meet the requirement of efficient professionals , you should consider improving yourself with our institute of clinical research.

This Clinical Research review will help you in considering a clinical research career in the field.

Related Topics:

1)5 Ways ResearchKit Is Revolutionizing Clinical Research

2)Crowd funding In Clinical Research

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Clinical Research For Physiotherapy

Clinical research is quite vital in the field of physiotherapy. Physiotherapists depends on information from researches to enhance the knowledge they have already gained through their university education and with continuous education courses.

Physiotherapists use the method of “evidence-based practice” as the basis for their treatments; based on quality controlled scientific research and clinical reasoning. Clinical research helps the practitioners keep updated with the latest in practice methods. With the knowledge gained from clinical research, the physiotherapists can explain that the methods CR specialists use to treat our patients are based on empirical evidence, peer review and sound clinical reasonings behind every principles.

There is a great deal of clinical research being performed in physiotherapy nowadays as has been the case for many decades. By regularly update of skills and taking on broad new proof based research, physiotherapists are at the cutting edge of developments in the healthcare sector and the physiotherapist have the scientific evidence to support their treatment methods.

As physiotherapists, they treat a wide array of medical conditions :

  • Spinal pain and injuries
  • Headaches
  • Sports injuries
  • Fractures
  • Musculoskeletal problems
  • Post-surgical rehabilitation
  • Biomechanical problems
  • Arthritic conditions
  • Neurological disorders and diseases
  • Cardiothoracic conditions
  • Paediatric conditions

A few to mention!

Physiotherapists are trained in manual therapy which means they are “hands on” with their patients. In addition to their manual skills they sometimes make use of different ways to reduce pain and inflammation including ice, hot packs,TENS, E-stim, laser treatment and ultrasound. Trigger point therapy and acupuncture is widely practiced by physiotherapists. The physiotherapy experts are highly trained in exercise prescription and often give their patients exercises to practice at home to help resolve their conditions.

The profession addresses neurological,orthopedic and cardiopulmonary problems among people of various age range from infants, children, adults and all populations.

Physiotherapy treatment might involve exercise to improve strength,

motion and endurance range and to correct imbalance of posture and muscle , joint mobilization, manipulation and soft tissue massage, as well as stretching and trigger point therapy to reduce stiffness and to relieve pain.

Patients with neurological disorders such as multiple sclerosis, stroke, cerebral palsy, Parkinson’s disease and spinal cord injury that can benefit greatly with physiotherapy methods. Interventions focus on muscle control, recovery of fine and gross motor skills, improve daily function, regaining of strength and flexibility, restoring and improving gait and training in the use of aids of mobility.

Cardiopulmonary conditions respond good to physiotherapy intervention. Patients who have difficulty performing their activities of daily living, or who have problem with shortness of breath and reduced endurance, can achieve improved quality of life through guided training. Intervention includes manual therapy and exercise to help clear congestion in the lungs, counseling about risk factors, patient education to prevent future occurrence and behavior modification. For those patients who have had cardiopulmonary surgery, physiotherapy is initiated at an early stage to prevent the patient from losing strength and function.

So the clinical trials that are ongoing worldwide, would definitely help with many novel techniques that would be more efficient, patient friendly and less time consuming.

Amidst many institutes in Pune, CRB Tech Solutions has created its own niche. Its very popular in giving the best training in Clinical Research. Our clinical research institute has created a name for itself in this field.

Clinical research jobs in Pune are increasing gradually and to meet the emerging need of efficient professionals , you should consider upskill yourself with our clinical courses.

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

Related Posts:

1) Clinical Research Organization

2) What is Clinical Research Organization and jobs in a CRO

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Clinical Research And Its Types

Clinical Research And Its Types Clinical Research is a booming industry of today’s time. Based on topics or area of interests, there are different types of clinical researches. Here we write about some different kinds of clinical research.

Clinical Trials
Generally involves psychotherapy, medication, new devices or new approaches to surgery or radiation therapy.

Prevention research
It investigates better ways to prevent disorders from developing or returning. Different types of prevention research might study vitamins, medicines,vaccines, minerals, or lifestyle changes.

Diagnostic
They looks after practicing better ways to identify a particular disorder or condition.

Screening
This aims to find the best ways to detect certain disorders or health conditions.

Genetic studies
This research aims to improve prediction of disorders by identifying and learning how genes and illnesses might be related. Research in this area might explore ways in which a person’s genes make him or her more or less susceptible. This could help in l development of tailor-made treatments based on a person’s genetic make-up.

Epidemiological studies
This helps to identify the causes, patterns and control of disorders in groups of people.

Note: Some clinical research is “outpatient,” which means participants does not need to stay overnight at the hospital. Some is “inpatient,” meaning that participants will required to stay for at least a night in the hospital or research center. You need to be clear about what the researchers and their study requires.

Clinical trials phases: when clinical research is used to evaluate medications and devices
Clinical trials are a kind of clinical research
programmed to assess and test new interventions such as psychotherapy or medications.

Clinical trials are done in four phases. Each phase has a different purpose and help scientists answer different questions.

Phase I trials
Researchers
experiment a novel drug or treatment process in a small group of people for the first time. The researchers try to find the treatment’s safety, determine a safe dosage range, and identify if any side effects.

Phase II trials
The experimental
medicine or treatment method is given to a bit larger group of people to see it‘s effect and hence further assess its safety.

Phase III trials
The experimental
novel drug or treatment method is given to large groups of people. Researchers confirm its effectiveness, supervise side effects, compares it to normally used treatments, and collect informations that will permit the experimental drug or treatment method to be used with safety.

Phase IV trials
Post-marketing studies are conducted after a treatment
gets approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

Examples of other kinds of clinical research
It’s a general belief that, all clinical research involves testing of new medications or devices. Well this is not the case always. Some studies does not involve testing medicines and a person’s regular medications might not need to be changed.

Healthy participants are also needed such that researchers can compare their results to results of people with the illness under study.

Some instances of other kinds of research include the following:

  • A long-term study which involves brain scans or psychological tests
  • A genetic study which involves blood tests but no changes in treatment methods
  • A study of pedigree that involves having words with family members to learn about people’s medical needs and history.

If you are looking for Clinical research course in Pune, then CRB Tech Solutions would provide with proper help and support. Its one of the best in offering training in Clinical Research.

Clinical research jobs are fast increasing and to meet the requirement of efficient professionals , you should consider improving yourself with our institute of clinical research.

Our Clinical Research review will help you in considering a clinical research career in this field.

Related Posts:

1) What Are The Types of Clinical Research?

2) Clinical Research Company

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Pharmacovigilance In Product Lifecycle

Pharmacovigilance In Product Lifecycle 

Part 1

Risk Management Planning critical for patient safety and product innovation

A safety signal is a possible relation between an adverse event and a drug, or a new aspect of a known adverse event and a drug, which involves some type of further investigation.

When a signal is detected, further investigation is needed to determine whether an actual relationship exists. The whole process of signal management is one of the most crucial steps in PV and is explained in numerous guidelines to various degrees. These includes the EMA Guideline on Good Pharmacovigilance Practices (GPV) Module IX.

Now signal management includes many processes, such as identifying sources of data, detection of signal, setting of priorities, analysis, evaluation and assessment with recommendations for action, and remains at the center of PV and drug safety. These processes are required for patient safety and by drug regulatory agencies. Keeping of records and documentation of the decisions, activities and results is also required. The outcome of the signal management process is dependent on the quality of the safety data and, as a result, improvements in the quality of safety data will have an impact on the effectiveness of signal management and PV as a whole.

The area of safety signal detection has come into focus over the past years and is growing in importance. It is well accepted that statistical methods of signal detection can initiate certain drug-event combinations for in-depth analysis from a medical perspective, potentially leading to confirmation of proof and signal identification. Signal detection can be completed using many methods, each of which has some advantages and limitations. New and improved computer-aided statistical methodologies are under assessment with the anticipation of offering improved specificity, sensitivity and predictive value.

The revised guidelines says about the importance for medicine developers to engage in early dialogue with EMA and other stakeholders, to achieve an understanding of the data package to be included in the application, including on the proposed risk management plan. Such risk management planning is critically important in particular in the context of conditional marketing authorizations.

During the yearly renewal of such authorizations an evaluation of the data accrued during the post -authorisation period takes place. The evaluation considers whether an update of the product information or risk mana gement plan is necessary.

Companies encouraged to seek scientific ad-vice for PASS

What’s new?

In the year, 2015 EMA started a pilot to encourage businesses to seek scientific advice for post-authorisation safety studies . This voluntary procedure will help to upgrade the planning for and the mode of studies meant to collect further info on a medicine being safe once it is on the market.

What do you need to know?

Any question relating to the collection of data and information on a medicinal product, or on risk minimization can be submitted via the scientific advice procedure. EMA encourages companies to get scientific advice in particular on non -imposed PASS.

What’s new?

In September 2015, EMA initiated the Patient Registries Initiative to make good use of existing registries and help the establishment of high-quality new registries.

The data collection from a patient registry is often needed of a marketing authorization holder (MAH) as part of a package of benefit-risk management measures on the safety or efficiency of individual products in routine clinical practice. Despite the previous existence of a disease registry, MAHs sometimes seek to establish their own product registry, potentially resulting in duplication of ef forts and a slow resolution of the starting concern. The initiative proposes a strategy to identify and evaluate current data sources and develop a methodological toolkit for establishing new registries if required. The initiative begins with a pilot phase to test different components of the patient registry process and if it meets regulators and other data and information requirements.

If you are seeking for Clinical research courses in Pune, then CRB Tech Solutions has created a niche for itself. Its known for offering the best of all training in Clinical Research.

Clinical research jobs are rapidly gaining significance and to meet the need of good professionals , you should consider improving yourself with clinical research institute .

This Clinical Research review of CRB Tech Solutions will help you support your clinical research career .

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