Best Practices Series: Know What WE Know About CRA Training

What should you look for in a Great CRA??

As anyone in the industry understands, a CRA has an integral role to play in the proper execution of a successful study. All CROs look for competent, qualified professionals when hiring their CRAs and there are certain professional characteristics they look for when doing so. Read on to discover the best practices and qualifications that CROs look for in a new CRA.

CRA's are the backbone of a clinical trial
CRA’s are the backbone of a clinical trial

Qualifications and Experience
While it’s true that everybody has to start somewhere, when looking for to hire a CRA, CROs are very concerned about clinical experience and the type of qualifications a CRA has. There is no law that requires a specific certification for CRA training but a candidate that has successfully completed a CRA certification program has proven their dedication to the industry. Furthermore, a great CRA has industry experience of some kind. A CRA should have at least a Bachelor’s degree in a scientific or medical field of study and preferably experience working in some aspect of the industry (such as a nurse or a lab technician).

Protocol Training
An in depth understanding of proper protocol is an absolute must-have for any new hire. As Dr. Summit, of Clinical Research Academy of America says, “If you don’t know GCP regulations, that is OK; make sure you know the Protocol!” Protocol regulations are what protect clients, participants and the integrity of the study. If proper protocol is not followed and the CRA is unable to recognize that, the validity of the study is in jeopardy. This translates into the loss of time, energy and money on the part of every entity invested in the study. A properly qualified CRA will be able to demonstrate best practices in protocol recognition and error correction.

Thorough Understanding of GCP
Good Clinical Practice (GCP) regulations are another field of knowledge that the best CRAs know well. A skilled CRA is able to note errors in GCP and suggest corrections before they invalidate a study. This is vitally important and one of the primary responsibilities of a CRA. A new hire must be able to satisfy an interviewer that he or she has a working knowledge of GCP and is comfortable monitoring a study-site for appropriate procedure within that framework.

Attention to Detail
A genuine understanding of procedural protocols and GCP, as well as clinical experience and a solid background in the industry are all necessary components to performing as a CRA. Yet knowledge alone is not what makes a CRA great. Interviewers look for characteristics that denote a personality that will shine as a CRA. A prospective hire must give the interviewer a sense that they have complete attention to detail and are comfortable taking the time necessary, even under pressure, to be thorough and exacting.

A CRA that can demonstrate best practices in the industry is an invaluable support person for a smoothly running research machine.

Got Questions? We have Answers! Contact us at?CriteriumBlog@criteriuminc.com

(Although some source material was found on the CCRA (Clinical Research Academy of America) website, it does not imply an endorsement or recommendation of the curriculum)

The Advantages of Translational Research Methodology

Applying basic research knowledge to practical applications is a well-known obstacle to?progress?in science. This issue is seen most often in medical science. There is often a lag between emerging scientific findings and their application as treatments to patients who may benefit from them.Translational research is aimed at taking basic science? research to the next level.?It connects new discoveries to application in patients.

Multidisciplinary Collaboration
There are four basic steps to consider in this research tactic.

  • Development of techniques to translate new knowledge generated in a lab environment, or at the bench level, to human testing
  • Refinement of human study results for? clinical use
  • Transference of practices from academic medical centers to use in the care of patients in community practice
  • Continued evaluation of data from the previous steps to provide confirmation of the efficacy and tolerability of new therapies

The goal of translational research is to quicken the transition from the lab to the patients who may benefit from the basic science findings. Thus translational research is a collaborative effort among basic researchers, academic physicians and community health professionals to provide new treatments to appropriate patient populations.

Funding Options
Translational research can potentially expand the funding options for a project.

  • Researchers benefit by working with a center that is able to provide seed funding. They reduce overall project costs by utilizing basic science center personnel for development of new therapies that then can be applied to patients in the community..
  • For universities, setting up a translational research center is a tactical approach to improving funding options. Through the research center, academic organizations develop strategic plans to provide improvements in public health benefitting overall community.
  • Communities benefit by gaining a stake in the study. The community becomes a contributing member of innovative medical research.

Stoking Excitement in a Field of Study
The developing barriers between research and clinical applications tend to dim interest in research projects. Moving towards a translational approach expands these possibilities. The power to take new knowledge from the bench to a clinic setting and then back to the bench for analysis lifts some of the impediments to expanding interest in a project.

Translational Science Research

Physicians in the community are able to see
basic research translated into practical application. A project that was once unapproachable due to time constraints and the complexity of the study boundaries will now draw interest and participation.

Translational research is a bench-to-bedside approach to medical developments. With this two-fold methodology, basic science presents tools to clinicians that have the potential to improve patient care. Clinicians are able to make observations and provide valuable feedback about the progression of disease that will lead to more discoveries. A translational model benefits the community by speeding the application of new research findings to patients and thus drives the clinical research progress at a quicker pace.

The Oncology Consortia of Criterium believes this methodology is the best way to speed results of research to benefit the public – it’s why we say we are “Changing the Way Cancer is Managed”.? Read more about our approach at the Academic GI Cancer Consortium or at the Academic Myeloma Consortia web pages.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 11 Apr 2013 15:07:00 GMT

Quick Takes: the Pharma C-Suite with Mary Stefanzick, Data & Operations Director


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?The Evolution of the CDL?- The Clinical Data Liaison

The CDL is a role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money.?Criterium has been utilizing the efficiencies of the CDL position since 2001. It is a successful tool we use to streamline our clinical trials.

The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager.? The best of both worlds.?

Within any CRO, a CDL is the link to a successful clinical trial. ?This individual has the ability to influence the three Cs of site management: connect, communicate, and control. This position is key in that he or she conducts real-time data review and facilitates centralized control of data management.?

To really improve the workflow process, the CDL is a clinical and data expert who connects team members ? sites, CRAs, and data managers ? through the use of data collection technologies that are used in a workflow that emphasizes real-time receipt and review. The ultimate benefit of the workflow that is managed through the CDL is to reduce the barriers between monitoring and data management.

Three of the most important reasons to utilize CDL?s in your study:?

REDUCES MONITORING COSTS
The CDL position combines the clinical research training skills of the clinical monitor with the data expertise and discipline of a clinical data manager. As such, CDL’s are the first to review CRF’s to make sure that the protocol is being followed.?

STREAMLINES DATA PROCESSING
They are responsible for timely review of data safety values, such as SAE’s, AE’s, lab values, and ECG’s that are critical to the safety of the patients; they do this in the context of the overall database. This is especially important, as the field monitor?s perspective is based on the review of individual site visits.


cdl chart for blog

COST SAVINGS
Because CDL’s monitor site data daily, they are able to identify potential problems before they arise thereby reducing the cost of field monitoring per patient by as much as half when compared with traditional monitoring.

Find out more about this efficient and cost-effective method of trial management:

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Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 28 Mar 2013 20:33:00 GMT

Best Practices Series: Communicating with Sites – Know What We Know

We asked two of our top CRA?s, Ed J. and Jaime H. to weigh in on the subject of ?Best Practices for Communicating with Sites?.? Here?s what they had to say in a nutshell:?

Ed:? First of all, sites are our most important asset.? Sites are valued customers for any CRO.? Maintaining good relations with sites helps achieve a win-win situation, ensuring timely patient recruitment and reliable quality data.?

Jaime:? To me, having a positive relationship with the sites is priceless.? Both sides will benefit greatly.? The sites need the CROs to help them manage the data.? It?s crucial to maintain open lines of communications so that you get all the data that you request.

EdJahn_th

Ed:? We rely on our?sites to take an active interest in each study protocol to be involved in and be knowledgeable of all the procedures and requirements.? This is extremely time consuming, even the smallest mistake can have a huge consequence.? We place enormous pressure on our sites to recruit and perform and without our support, without good relations, we run the risk of creating negativity.? A strong association ensures a good communication and responsiveness.? It?s a two-way street.? It should be just as good from the site?s point of view as it is from ours.?

Maintaining pleasant but professional relationships with sites is one of the first important steps of being a CRA.? Without a good pleasant relationship, you lose the personal connection with your site.? CRAs have to straddle the line between serving the sponsor and still understanding the site?s interests.? CRAs can sometimes be perceived as individuals coming from big pharma companies with an attitude that says we?re in charge.? This can set a negative tone which makes working with sites much more difficult.? It?s important for everyone to recognize their respective expertise.? Sites are experts in their field and CRAs are experts in?theirs.? Together they make a strong study team.?

Jaime_thJaime:? I agree with that.? The respect has to be mutual.? If the CRA treats the site in a friendly, relaxed and professional manner, you?ll likely get the same attitude back from the site.? The study coordinators are the main focus as they do pretty much the bulk of the work.? It?s crucial to treat them with the same respect that you?re entitled to, to ensure they?ll be happy to assist you when you need something.

Want to hear more from Jaime and Ed?? Send us your CRA and Clinical Trial questions and we?ll post the answers here!

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersMon, 25 Feb 2013 19:25:00 GMT

Quick Takes: the Pharma C-Suite with John Hudak, President Hudak-President

john hudak quote_325We have successfully conducted trials for over 20 years – since 1991.
Criterium?s mission to provide our clients, staff, consultants and sites an extraordinary experience, with integrity.

Our focus, for every client, is simple, and we mean it:? Provide Quality Solutions.? Reduce Costs.? Accelerate Timelines.? It?s the root of our business philosophy.? We respond very quickly to clients from their first contact with us for a bid proposal to every aspect of the projects we win.? Every single person on our staff is aware of these company directives and works towards them.? This is a very real, daily, activity for us, not just words.? When I look ahead at the next twenty years, I am enthusiastic about what lies ahead in this field and committed to establishing better and more efficient ways to support drug development, to cut costs and to improve technology resources directly related to these initiatives.

We offer the broadest range of services in our market niche, because we CAN.? We have staff from all aspects of clinical research experience?? that allows us to do that.? It?s a unique mix of incredibly bright and dedicated people ? I am very fortunate to have them.? As a medium-sized CRO we can be more agile, and have the advantages of moving more quickly than the larger, leviathan CRO?s, starting and completing trials more efficiently, and giving clients a much more personalized, one-on-one experience. Our unique technology-based paradigm allows us to respond to sponsor needs in specific detail and to deploy trials rapidly throughout the world for fast, successful trials.

Our clients are among the top 10 pharma companies to small venture capitalized biotechnology and new formulation companies. They are USA domestic and they are also based in Europe, Israel and Asia. We have worked with generic companies when they need to have bioequivalence studies with clinical endpoints done.? We have a satisfied client list as varied as the therapeutic areas in which we have experience.? Our personalized service experience and ?Get to Know Us!? philosophy has proven to serve our clients well.?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

John HudakThu, 17 Jan 2013 22:45:00 GMT

Best Practices Series: Know What WE Know About ICH GCP

The ICH (international Conference of Harmonization) plays a major role in providing pharmaceutical standards, accepted by regulatory authorities across the globe, and GCP (Good Clinical Practice) is no different.? The ICH GCP guideline was developed with an aim to protect the rights and safety of human subjects while assuring credible and internationally acceptable clinical trial data.? Along with WHO (World Health Organization) recommendations, the international ethical and scientific standards for clinical trials involving human test subjects (GCP) from the regions of Europe (EU), United States of America, Japan, Australia, Canada, and Nordic countries were all taken into consideration.

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Importance of GCP
It is safe to say that GCP in clinical trials requires a lot of time and resources. While following best practices protocols when conducting a research does yield more reliable data and strict ethical protocols protect the subject rights and safety, the GCP for any study was in the clinician?s domain until relatively recently. However, loose GCP protocols were not acceptable by regulatory authorities and The Declaration of Helsinki in 1964 provided a foundation for internal GCP guidelines for many organizations.

Under ICH GCP, all crucial aspects of best practices were unified under one guideline. For the independent researchers or noncommercial trials, this guideline can feel to restrictive and demanding, bringing extra paperwork and increased cost. However, the document represents the way of thinking that should be always present, when conducting trials on humans; the same rigorous quality, ethical, and safety protocols should be followed, regardless of the trial type or origin.

ICH GCP and Its Principals
Frequent poor data monitoring, flawed statistical design and analysis, and questionable ethical methods used in clinical trials in the past have all contributed to a growing public and professional concern about research misconduct, and have lead to misleading, and sometimes even hazardous trial results. ICH GCP plays a vital role in assuring sound clinical trials and reliable trial results while protecting the patients rights and safety.

Ethical Aspects?
Clinical trials should be conducted in accordance with the ethical principals of the Declaration of Helsinki, and a study should be conducted only if the potential benefit for the society outweighs the possible risks for the subject.

Clinical Protocol
The trials should have scientifically sound and clear objectives, supported by prior clinical and nonclinical information, and should be conducted in compliance with a detailed protocol, approved by IRB (institutional review board) or IEC (independent ethic committee). Freely given informed consents should be obtained from every subject in the study.

Record Keeping
Every individual involved in conducting a study should be properly educated and trained, all clinical trial data should be properly recorded, handled, and stored, and the subject’s confidential data should be protected.

Study Report
The study report needs to be prepared at the end of the study, regardless of the study phase or the number of participants that were included in the trial. Following ICH GCP principles is crucial to providing significantly increased quality of treatment.

While some of the procedures in the ICH GCP can seem tedious, past experiences shows all of them make sense. Not only do they provide a safe environment for the participants, and improved treatments for society, they ensure that negative trial results are well documented and can prove as useful as positive results in future clinical trials. Along with the obvious benefits of complying with the best practices, apparent hindrances, such as increased bureaucracy and cost, can be greatly reduced with proper study design and utilization of approved clinical trial system and experts.?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersThu, 03 Jan 2013 20:57:00 GMT

Translational Science for Cancer Research – The Consortia Model

Cancer Exploration for the New Millennium

What advantage does a clinical consortia group have over regular trial groups when it comes to innovative cancer treatments???In some important ways, through Translational Science methodologies. The most important conceptual difference between the classical clinical trial and the Consortia approach is that the Consortia model, with its highly experienced clinical scientists, is involved on an intellectual advisory level with every step of clinical investigation in a cancer study. ?Classical clinical trials groups most often have patient accrual as their most substantive role.
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cancer-attackA Consortia can readily interface translational science with clinical outcomes and can show the value of translational science to a positive outcome of regulatory approval process and is critical to the Consortia?s contribution to research projects. ?Consortia institutions have the capability to collect tissue and have access to labs to analyze and interpret data. Consortia sites have been selected for their access to patients with specific diseases and for their ability to enroll such patients on clinical trials.

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Here’s why: The discipline of clinical and translational science encompasses a broad spectrum of research, extending from basic discoveries with implications for human health to community-based epidemiologic and health services studies. The unifying theme is a commitment to apply scientific methodologies to address a health need. SCTS (The Society for Clinical and Translational Science) defines it as:? “…a multi-dimensional, cross-cutting discipline that encompasses multidisciplinary investigative teams from many different subspecialty areas. Moreover, success in clinical and translational science commonly requires constructive partnerships with industry, granting agencies, public health agencies, and regulatory agencies.”

Criterium’s Core Science Solutions’ Academic Consortia’s for both GI and Myeloma use the translational science model and can streamline cancer treatment research. Take a look at: https://www.criteriuminc.com/css.php?or visit?www.agicc.org and www.ammyc.org?

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Claire WyntersFri, 19 Oct 2012 14:29:00 GMT