Monthly Archives: April 2017

6 Benefits Of An Agile Approach For Interactive Response Technology

During clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and make sure the study design is balanced and trial supplies are available when and where they are required. A key piece of those efforts is the usage of interactive response technology (IRT) software.

Conventional RTSM study build processes follow a sequential, waterfall approach that could be quite time-consuming. Business analysts work with vendors to write study requirements and specifications, which is followed by a build phase to implement those requirements. A final validation period verifies the needs.

Vendors previously attempted to streamline these processes using web-based configurations that permit companies to quickly set up trials. Some of these tools allow studies to be set up without custom coding, removing the extensive development time required to write new software for every individual study. To mention, creating lengthy specification documents before starting the study could create inefficiencies, generate unnecessary customizations and lead to significant re-engineering of the study after the testing phase.

Current approaches to IRT based on traditional methodologies could introduce extra costs, time and errors into the study build process. A novel and agile approach that involves customers quite early in the development cycle could result in improved quality, faster deployments and lower overall costs. This agile approach, which is based on existing agile software development methodologies and principles, could reduce the back-and-forth that occurs during the user acceptance testing (UAT) and quality control phases.

The agile model encourage adaptive planning, evolving development and the use of functional software in vendor/client interactions rather than the development of specification documents prior to the study build. The client could evaluate this software demonstration and provide immediate feedback that could then be used to rebuild the study. And while there might be some cost associated with that rebuild effort, the cost is relatively low enough that the specifications don’t have to be perfect in advance of the study build. Once the build process is complete, the final specifications could be constructed to align with the as-built study exactly, which results in a faster sign-off and approval process.

Theis approach not only improves the process efficiency, but ultimately results in a higher-quality study. By streamlining the process and getting clients involved earlier, the following benefits could be realized:

1. Higher Efficiency and Quality

While this IRT approach makes the build process faster, speed is not definitely the primary force. The real benefit is that it enhances the efficiency of the entire process.The time spent building the study is quite productive, and there is less waiting between process steps. It also improves the quality of the finished product because the team could focus on solving problems rather than the development of intricate specifications.

2. Earlier Problem Resolution

With the software right in front of them, the study team could immediately spot errors or identify incorrect assumptions they made early on in the process about the structure of the system. They could also avoid overlooking flaws in the study that might otherwise be missed in UAT.

3. Faster Project Completion

The study could be configured much more quickly, which could significantly lower study build time. While a standard study takes 6 to 8 weeks to build, an agile approach can often be completed in much lesser time.

4. Lowered Customization

Clients have a chance to see that the core configurable IRT system can meet most of their requirements without a high level of customization. By seeing the working of the system quite early, they can visualize how the solution could meet their needs.

5. Lesser UAT Findings

The collaboration provided by agile IRT must result in a UAT phase with fewer findings and less redevelopment. This further streamlines the process because clients don’t have to dedicate resources to testing for lengthy periods of time.

6. Lowered Time Investment

The client spends lesser time on the study build process. While an agile approach needs a greater level of collaboration and availability on the part of the client, it ultimately lowers their investment in time and resources by lowering the effort needed for multiple rounds of specification development and multiple UAT cycles. A high quality study also reduces the maintenance effort needed to run the study.

IRT software helps streamline and simplify the RTSM process, but the reliance on developing elaborate specifications documents before the study build adds time and cost that can be avoided by improving collaboration between researchers and the study build team. Agile IRT could lower the cost and time neede for the study build process while also leads to a higher quality study with fewer UAT findings.

We conclude now.

Whichever way you want to take your career you do; CRB Tech Solutions is here to guide you in your Clinical Research Career. We conclude the discussion here. Stay connected with us this space for more discussions.

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 fulfill 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

Risk Management At Different Levels

The revisions in ICH E6 (R2): Good Clinical Practice have earned a lot of attention, not because of the recommendations for the incorporation of a formal risk analysis when planning and executing trials. The starting point to manage risk effectively is adopting a suitable risk analysis and mitigation method, such as risk scoring or failure modes effects analysis. We must understand what could go wrong, what happens if it occurs, how likely it is to happen and how likely we are to detect it happening.

These methods enable to view risk with a more objective eye. Often, the effort reveals unexpected risks or changes the understanding of the risks that must be prioritized.

The use of risk management methods is popular in pharmaceutical industry for many years, and the concept itself could and should be applied to planning and executing all activities. Below, we note some ways that must be considered during managing risk at the enterprise and clinical trial execution levels in the selection and use of a randomization and trial supply management solution (RTSM).

Analyzing risk in business processes

Risk analysis must be applied to the 3 core elements of the business process mentioned below:

Procedure Helps follow to ensure consistent outputs
People Include correct skills and training to execute the procedure
Tools Used to support or drive execution of a procedure correctly.

Procedures give operational control as well. People considerations include hiring the right people in house for the job and having appropriate vendor selection and management of outsourcing strategies. Tools could include the equipment for manufacturing, labelling and storage, as well as the selection of trial management tools like RTSM. A preferred vendor RTSM solution could provide opportunities to standardize practices that cause the results of your risk mitigation strategy.

Managing risk at enterprise level

Often, in big organizations, institutional practices and structure are inherently created to manage risks. In such organizations, a periodic assessment could be used to understand if the risk map changed. E.g., at the enterprise level, some pharma companies have moved to cold chain products in recent years, as well as products that require associated bulk supplies such as injectors. This has triggered transformational change in the clinical supplies supply chain from the teams responsible for manufacturing, labelling, and distributing to those responsible for monitoring storage and accountability of study drug at clinical trial sites, relating directly to the effective use of RTSM systems.

On RTSM selection for enterprise the following must be considered:

  • Service delivery
  • Feature-rich systems
  • Integration
  • Continuous improvement

Risk management in trial planning

This level starts with protocol design and continues from there. The selection of RTSM tools could be made on a gradual and systematic protocol basis, but this demonstrates how the planning of trial execution should inform our risk analysis for tool selection and implementation. Questions here include:

  • Which vendor gives an implementation process that minimizes risks of missed milestones for release, incorrectly understood needs, and post-release errors?
  • Which vendor has domain knowledge and how to use it in a good approach where they actively contribute to risk mitigation in the trial?
  • Which vendor could demonstrate a scalable process and models?
  • Change during a trial to be expected.
  • Which vendor offers monitoring tools that, allows you to get the maximum value for trial oversight from the data captured or generated throughout a trial?

These are only a few of the questions that are raised and discussed in sponsor, Contract Research Organisation, and vendor settings weekly.

We conclude now.

Whichever way you want to take your career you do; CRB Tech Solutions is here to guide you in your Clinical Research Career. We conclude the discussion here. Stay connected with us this space for more discussions.

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 fulfill 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

Career Opportunities After MSc Clinical Research

Clinical research is a booming industry and is gaining importance now. Most of the countries, including India is becoming actively involved in clinical research. MSc clinical research is a postgraduate degree that could be helpful in this sector.

Masters in Clinical Research is yet not a very popular course among students.

The main reason for such a low demand is low level of awareness about the discipline and the job prospects. But those who are studying and working in pharma sector are well versed with the height of career prospects.

Clinical research industry has reported wonderful growth in the past years and is in need for professionals that are well versed and educated. MSc in Clinical Research helps the students to acquire the necessary skills and make good career in this field. There are many reputed schools across the globe that offers this post graduate course. It is a known fact that in order to make a fruitful career in any field one needs proper and higher educational qualification.

Clinical research deals with many aspects that include researching with medical equipment and medicines on the subjects of safety and performance. It is an important industry and the development of the healthcare sector highly depends on clinical research. The course MSc clinical research is a step towards the people looking to make big in the field of clinical research. In order to pursue this course one must have a bachelor’s degree in science or pharmacy as well. The schools which offer this course makes sure that the students attain the best possible education.

There are several good job opportunities after completing MSc clinical research. Research institutes worldwide keep posting job opportunities for people who have apt skills and education. A bright career in clinical research is equally fruitful and good money wise as well.

Job Opportunities

Clinical Research opportunities after Masters:

CRM are Clinical Research Managers:

They supervise designing and writing of protocols, case report forms and informed consent forms for clinical trials. They makes sure that Case Report Forms are reviewed timely and submitted to the data management group.

There are various growth prospects along the way. For those interested in research work, a PhD is the ideal choice. There are post graduate degrees and diplomas offered by various colleges which enhance one’s career prospects. Specialization in branches of pharma, life sciencesand biochemistry would be useful.

Studying further would also help in bettering their current job profile. A PhD in a related branch is must to become a Medical Director. According to industry reports, India owns the second largest pharma market in Asia and is growing by over nine per cent annually.

Some Related Alternative Careers

For individuals who have earned master’s degree, they might be interested in a couple of medical related careers. Medical assistants might work in hospitals, clinics, or doctors’ offices. Their main responsibilities include meeting with patients, discussing and recording their medical history, measure vital signs, administering medicine, and coordinating with the doctor. You could also consider a career as a medical or health services managers. These professionals take in charge of a variety of administrative and executive tasks in a hospital or clinic.

We conclude now.

Whichever way you want to take your career you do; CRB Tech Solutions is here to guide you in your Clinical Research Career. We conclude the discussion here. Stay connected with us this space for more discussions.

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 fulfill 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

Pharmacovigilance and Drug Safety In Clinical Trials

Drug options selection includes perspectives from various disciplines (drug discovery, drug safety and drug metabolism), pharmaceutics, clinical pharmacology and biostatistics).  Many organizations make use of the fail fast model by integrating development functions into discovery to minimize failures in preclinical studiesMoreoevr testing allows organizations to select better compounds and to build better, long-term development plans.

Clinical proof-of-concept is a critical milestone that needs translation from animal pharmacology models to man. Making sure drug and metabolite exposures in plasma and at site-of-action is critical to validate the model.  In the central nervous systems (CNS), measurements in cerebral spinal fluid yield penetration or effect.  For anti-infective agents, tissue penetration or intracellular studies ensure that the minimum inhibitory concentration (MIC) is covered.

Drugs that bind with high affinity, free fractions might drive penetration and effect. Building pharmacokinetic/pharmacodynamic (PK-PD) models then needs protein binding.  For others, total drug levels drive pharmacology.  When moving into the clinic, translation of the pharmacology model to clinical effect should be accomplished as quickly as possible.

The No-Adverse-Effect Level and Dose-Limiting Toxicity

Establishing a safety margin is a crucial aspect that drives candidate selection. Knowledge of the no-adverse-effect level (NOAEL) and dose-limiting toxicity in the most selective species is critical, as these determine what doses can be given in man.  If metabolism-mediated toxicity is seen, examination of inter-species differences provides insights into relevance to man.  U.S. Food & Drug Administration (FDA) Metabolites in Safety Testing (MIST) guidance requires knowing 10% metabolites at steady-state, and bioanalysis using tiered assays plays a critical role in getting these assessments done early.  Many organizations delay clinical absorption, metabolism and elimination (AME) studies, with preference to establish early metabolism coverage without the use of radiolabel studies.  Bio analysis of animal tissues for parent drug and metabolites provides great insights into whether a toxicity seen in animals may be seen in man.  Worldwide has customised many bioanalysis plans to accommodate early metabolite determinations, helping make informed decisions about drug candidates.

Building an accurate safety margin in animals is more straight than defining human safety in large populations. Apart from the numerous human variables, concomitant medications can result in drug-drug interactions (DDI) that modulate drug exposure or effect.  FDA has guidance on how to predict in vivo DDI from in vitro metabolism, and scientists must ensure that a drug is tested in cytochrome (CYP) P450s and carriers.  Knowing whether a drug or its major metabolites are substrates, inhibitors or inducers is critical before allowing drug candidates to progress into studies where the interacting drugs are onboard or into sensitive (hepatic, renal impaired) populations.  Worldwide has supported numerous DDI studies using a variety of drug assays as probe substrates.  We recently presented a comprehensive assay of all warfarin stereoisomer which was used to unravel a clinical DDI4.  Worldwide also has several hundred validated drug assays which can be used to test drug interactions of selected inhibitors or inducers. 

The Increased Use of Personalized Medicine

The use of personalized medicine has increased, not just to target individuals who respond to therapy but to ensure that the proper dose is given.

Drug liabilities might be uncovered from metabolism or DDI studies, based upon observed differences in clearance. One can also select these populations based upon their pharmacogenetics for more focused PK testing. 

New Advances Highlighted at ASCPT & CPIC Symposium

The CPIC Symposium which was recently held with the American Society for Clinical Pharmacology and Therapeutics (ASCPT). summarised the BIA 10-2474 first-in-human (FIH) trial.  The cause of the brain lesions and death which occurred in this FIH trial is still being investigated.  The steepness of the toxicity-response on a 2-fold multiple dose escalation was particularly puzzling, especially as higher single doses were given without incident.  It was a stark reminder of the importance of vigilant investigators and oversight from Institutional Review Boards (IRBs).

Contract Research Organization (CRO), regulatory, legal and pharma perspectives on ensuring subject safety in FIH human studies were covered at the meeting among several topics, including clinical designs which could lower these risks.

We conclude now.

Whichever way you want to take your career you do; CRB Tech Solutions is here to guide you in your Clinical Research Career. We conclude the discussion here. Stay connected with us this space for more discussions.

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 fulfill 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

Fresher Jobs For Clinical Research Students

Clinical research is a booming sector that determines the efficacy and safety of new drugs. With ongoing researches in advanced level and more businesses considering this as their investment sector; there are also many job opportunities for the fresher and expert level. Here we discuss the job opportunities for the fresher. There’s a great need for talented and skilled people in the business.

To make an entry into this field, a candidate should hold a degree of B.Sc. The clinical research sector can be joined after graduation in life science, pharmacy and medicine. Bioscience further includes sub-disciplines like genetics, botany, biochemistry and zoology. People with educational qualifications from these fields can try into this sector.

The field has several branches. The common fresher level roles include the position of a Clinical Research Associate (CRA). A CRA is a key person in the planning, execution and supervision of the trials. They assist in making of manuscripts and presentations for scientific meetings and technical journals and visit meetings and training programs. Hence there is a high demand for clinical research associate jobs for fresher.

Another good position in this sector is Clinical Research Managers (CRM). They manage the planning and writing of protocols, consent forms and case report forms for trials. They ensure the case report forms are regularly reviewed and handed over to the data management group. Similar positions are Clinical Research Investigator, Clinical Research Coordinator, Business Development Manager and Clinical Data Manager.

There are many good institutes that offer clinical research programs. Among the top institutes of clinical research in Pune is CRB Tech Solutions. CRB Tech has created a name for itself among the best clinical research institutes in Pune.

The Clinical Research Training program by CRB Tech Solutions provides all the guidance to key skills and knowledge in clinical research using an innovative method. The program is for duration of 4 month and consist of lectures, internships, live projects and development of soft skills.

Participants after achieving all the program objectives, and on clearing all their dues and on securing 90% attendance receive a Certificate of Completion.

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 training jobs in Pune are increasing and to fulfill 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

Top Training Institute Of Pune In Clinical Research

The clinical trial industry is growing with a positive metamorphosis in India. Now the clinical trial processes are being viewed as innovations rather than drug development sector only. At present, several companies are looking for the best candidates who could join them in their success and to attain that bridge between the companies and the candidates joined the league of clinical research institutes who provide training and courses in clinical research.

With the presence of multi-national companies who establish their research facilities in India and with upcoming clinical research organisations, clinical sector is likely to develop exponentially. With increasing job opportunities in the clinical research field today and for the coming future there is a huge demand to grow the drug pipelines swell.

The famous player of Pune among the clinical research institutes is CRB Tech Solutions who has created a niche for itself in the field of clinical research training. The institute is gaining prominence with its finest Certification Program that has qualified more medical scientists around the country since its beginning. CRB Tech enables with live clinical sessions at labs and with its updated infrastructure it is marching forward in the race among others.

With its 100% placement assurance, Clinical Research Training Program of CRB Tech is the finest choice among the students.

The Clinical Research Training program by CRB Tech Solutions provides all the guidance to key skills and knowledge in clinical research using an innovative method. The clinical research program is a 4 month certificate program consisting of lectures, live projects, internships and development of soft skills. The training program includes a detailed CRA course for your advantage.

The modules of Clinical Research Training Program are upgraded and redesigned on a periodical basis by our industry expert. There are regular campuses drives take. CRB Tech also provides training in aptitude which is a part of the syllabus as it enables one to successfully overcome the hardest of the aptitude tests, which one faces in the interviews

We conclude now.

Whichever way you want to take your career you do; CRB Tech Solutions is here to guide you in your Clinical Research Career. We conclude the discussion here. Stay connected with us this space for more discussions.

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 fulfill 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