The Trial Master File 10 Essentials for Success

A Trial Master File (TMF) is a collection of all essential trial documentation that enables effective monitoring, data integrity, and compliance throughout the lifecycle of a clinical trial. Learn about best practices and approaches for Trial Master File management.

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Quick Takes: the Pharma C-Suite with John Hudak, President: Outsourcing & Strategic Partnerships

In the recent PharmaVoice Feb 2016 PV MagCover FEB16 issue highlighting Outsourcing, PV asked Pharma’s KOL’s to answer some key questions regarding the current state of Outsourcing & Strategic Partnerships.

John Hudak, President & Founder of Criterium Inc Global CRO
John Hudak, President & Founder of Criterium Inc.

John M. Hudak, President and Founder, Criterium Inc., answered these 2 questions for them:

  • What barriers continue to limit CROs and sponsors from becoming true development partners?

Sponsors can have unrealistic expectations of CRO partners. Most partnerships work top-down at both Sponsors and CROs, and are evidenced in timelines and budgets. But top-down management may not always translate into trickle-down commitment. There are some discouraging figures out there about the high percentage of studies that don?t meet their timelines. When timelines and budgets are estimated to satisfy board members or project committees, it?s imperative to include all key factors that affect early planning stages, and be grounded in fiscal reality.

  • What are the key ingredients to a successful outsourcing partnership?

Planning needs transparency and communication, in concert. Sponsors can sometimes have impractical expectations regarding timelines and budgets. And CROs can end up having the same unrealistic expectations of study sites. Everyone wants to meet expectations and win the job ? but this sometimes results in unworkable time estimates and budgets. There needs to be more open discussion among stakeholders, Sponsors, CROs and sites regarding the environments in which studies are conducted — and realistic strategies for successful completion.

About John M. Hudak, MBA, President and Founder
John has more than 40 years of experience in the pharmaceutical research and business development arena serving the pharmaceutical and contract clinical services sectors. He has extensive expertise in strategic planning and competitive analysis, market development, promotional planning and tracking, proposal design and custom-services development, international project management and clinical study completion, protocol design and implementation, electronic data capture, and market communications and has worked with drugs, biologics, generics and medical devices.

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If You Have Penicillin Allergies, You Should Get Retested

Patients who have been diagnosed with penicillin allergies probably aren?t allergic to it anymore, according to a new finding. The allergy wears off over time, but most people live the rest of their lives believing they’re still allergic, and pay for more expensive, unnecessary medication.

by Samantha Olson? Release Date: November 9, 2014

Mayo Clinic Allergist Dr. Thanai Pongdee, and his team retested 384 patients and found 94 percent of them were not allergic. The patients were scheduled to undergo several different types of surgeries when they were tested. Pongdee said he expected they would find maybe half of the patients still allergic to penicillin, a common medical allergy. However, when almost all of the patients found they weren?t allergic, it more than confirmed a suspicion doctors had for a long time.

Test Tube Penicillin
Test Tube Image Courtesy of Shutterstock via RePubHub

“We knew that the majority of people who list penicillin as an allergy actually aren?t allergic when they are reevaluated, so if you can determine they are not, you can avoid using more toxic and more expensive antibiotics,” Pongdee told NBC News. “It doesn?t happen very often that a health care provider challenges the presumption that the patient is still allergic. Many don?t realize that this is something a person may lose over time.”

When a patient walks into the hospital, one of the first questions they?re asked is, “Are you allergic to any medications?” Ten percent of the population report they’re allergic to penicillin, making it the most commonly reported drug allergy, according to the American College of Allergy, Asthma & Immunology?(ACAAI). A patient with an allergy may develop hives, swelling, throat tightening, wheezing, coughing, and difficulty breathing. In severe cases, it can cause a patient to go into sudden anaphylactic shock, which will rapidly worsen and could become deadly.

Penicillin has been around since 1928, and has been used to treat a variety of conditions, such as strep throat, ear infection, or sinus infection. Penicillin is the base of many front-line drugs, and if you can?t take one of those, you?re often forced to take a more expensive alternative with more side effects.

When one Long Island mother, whose son was diagnosed with a penicillin allergy at the age of 8, was asked if she would have him retested, she said, “I definitely would. It would stop us from worrying because he doesn’t wear a bracelet. He broke out in a rash and hives after he was given amocycillin for his strep throat.”

In most cases their sensitivity to penicillin will lessen overtime and can be treated safely with the drug. It?s exciting news for patients with documented penicillin allergies because they can start receiving cheaper drugs, such as the generic penicillin-based amoxicillin used to fight bacterial infections. Most people are diagnosed when they are toddlers due to an adverse reaction, but then live the rest of their lives avoiding a drug allergy with unfounded fears.

?There are two issues: these patients are put on other antibiotics which [are] less effective and potentially have more side-effects,? Family Allergist Dr. James Sublett, the incoming president of the ACAAI told NBC News. ?The other is cost. A very commonly used substitute, for example Levaquin, is seven to eight times more expensive for a 10-day course than a similar course of generic Augmentin, a penicillin drug.?

(Reprinted with license and permission from Medical Daily)RePubHub Banner



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Quick Takes: the Pharma C-Suite with Ronny Schnel, Exec. Dir., Business Development & Client Services

Ronny Schnel Exec Dir Client Services

Importance of Client Services

When clinical trials project management is paired with effective client services it becomes the framework for the most crucial tasks a Clinical Research Organization (CRO) performs other than the trials it runs. Why is this imperative for executives in the Pharmaceutical development C-suite to focus on this?

The multi-million dollar price tags of the projects undertaken in the competitive environment of pharmaceuticals and drug development dictate the need for a strong liaison between the project management team and their customers. In addition, every CRO needs to adopt and maintain a service-oriented mindset focused on business development and sales, in order to be successful.

And not just the sales team ? a customer-centric focus starts with Client Services, but all employees who have contact with a customer need to keep this in mind:

It’s all About the Customers

Clinical Research Organizations who acknowledge the importance of making initial contact with valuable customers, keeping them as satisfied customers, encouraging them to return, and requesting referrals reap the benefits of a focused client services program. To accomplish this goal, a CRO must create strategic client services policies and procedures. Some of these might include the following:

  • Find and connect with the customers: Every CRO should maintain a database of contacts derived from networks, conferences and personal contacts.
  • Communicate with customers through quality content: It is of the utmost importance in order to attract the level of customers to compete in a tough pharmaceutical market. With today’s technology, digital content is always in front of consumers and it creates leverage for a CRO over competitors NOT engaged in digital content marketing, as well as help build long-term customer relationships.
  • Listen to needs and wants of customers: A recent large C-Suite study[1] involving over 23,000 executives revealed three major insights indicating that every CRO must: (1) acknowledge and act on customer influence and input; (2) implement digital strategies that connect with the customer base; and (3) improve the overall customer experience.?Client Services taking care of customers
  • Give customers reasons to remain: If a CRO remains in touch with the expressed needs, wants, and input from customers, those customers will remain loyal to the CRO and create repeat business — the key goal in the client services arena.
  • Request referrals from satisfied customers: It’s the same in nearly any business: keep customers satisfied, and they will provide word-of-mouth advertising and referrals in return.

Consider This

It’s simple, really: Consumers become customers of a company or organization because they want or need a product or service; they remain customers and refer others as long as that company or organization keeps them satisfied. If a CRO fails to satisfy its customers, they are likely to go elsewhere, just like any customer would. This is why every CRO needs to have effective client services in place as that bridge between the clinical trials and project management teams and their valued sponsors and customers.

[1] Source:

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How does Criterium Rescue a study experiencing recruitment obstacles?

Global Clinical TrialsOne of the major requirements for a clinical trial to be successful involves the recruitment of an adequate number of participants so that?accurate scientific conclusions can be made. “Adequate” means that an appropriate sample size has been calculated such that even when some drop out of the study, as is commonplace in clinical research, the remaining enrollment will be adequate to allow meaningful evaluation of data.

A problem arises when a study is in progress, but too many participants leave the program so that the remaining number is too small to provide the required amount of data to provide a statistically significant result. It is our experience that this occurrence often leaves the Sponsor in a position where they begin to seek alternative options in managing the study.

Analyzing the fall-off to get back on track

As a CRO we are experienced clinical trial project management specialists. We know how to turn a slow recruiting or high dropout study into one that fulfills the requirements of the statistical analysis plan. We return the study to a viable and productive state using the most cost effective methods. We analyze recruitment and retention plans and identify the problems.

Once identified, we provide suggestions and an implementation plan for how they can be resolved. Our step-by-step approach includes the following:

1) An intense review of the study with the study team. We develop a thorough understanding of all aspects of the clinical trial including the recruitment strategy that was implemented to understand the shortfalls.

2) We gather as much information as possible in order to identify what the recruitment and retention problems might be caused by through the conduct of the following types of field interviews.

  • People working at sites that are successful and sites that are struggling
  • Other identified knowledgeable sources that are not actively involved in the study but may provide valuable input,
  • Physicians and community groups who have the potential to provide referrals

3) We analyze the data we have collected in order to identify the factors that are responsible for recruitment and retention obstacles.

4) We provide you with a detailed report of our findings and the most cost effective solution(s).

5) We meet with you in person, whenever possible, to review, discuss and brainstorm ensuring that we rank the obstacles from most to least critical.

In this way, we prioritize the solutions — especially when dealing with budgetary constraints. Clinical Trial RescueBy gaining important feedback, using our own experience and by working together through a team approach, our clinical trials project management team is able to provide you with a complete understanding of the recruitment and retention obstacles faced by your study.

Our experience and confidence in this approach allows you to take immediate action to get your study back on track towards meaningful and significant results.

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The FSP: Functional Service Provider in Pharmaceutical Research

A Functional Service Provider (FSP) offers a variety of clinical trial services on an “a-la-carte” type basis – as opposed to a full suite of services. This allows large Pharmaceutical companies to outsource only what they need to fit their budget (and other factors).

This blog article discusses how a COLLABORATIVE APPROACH to understanding the clients? needs and GOOD LISTENING SKILLS on the part of the service provider, make offering a partial selection of services (as opposed a full suite of services) a practical and cost effective approach to pharmaceutical drug development in this economic climate.

FSP Group Conference
FSP’s are able to plug-in to all parts of a study; Criterium’s a-la-carte menu of services offers sponsors the ability to get expert personnel for just what is needed.

As more and more pharmaceutical companies are outsourcing the management of clinical trials to Functional Service Providers (FSPs) there is a need for constant and competent communication between the Sponsor and the FSP?s who are providing specific clinical trial services.? This is not something to take for granted as communication will be the key to a successful project. The pharmaceutical company owns the project, while the FSP manages some aspect of it. Although a solid contract that is legally binding is always negotiated between the pharmaceutical company and the FSP, both entities will find that a good working relationship depends on open communication and collaboration.

Collaboration is a Must
Collaboration simply means working together to create something new. There are many different ways that the management of clinical trials can be outsourced to FSPs, but all require collaboration between at least two entities. The involved companies must have a shared plan as well as the right people and tools to work on the project.

When pharmaceutical companies outsource clinical trials, even though they still own the project, they must work together with the FSP. In fact, a pharmaceutical company may outsource different parts of a project to different FSPs. In order to create a satisfactory end product, they must all collaborate and set up parameters to delineate which entity is responsible for which tasks. In addition to emails, telephone calls and regular reporting, face-to-face meetings must be part of the collaboration process.

Need for Clear and Constant Communications
Collaboration requires clear communication. Just some aspects of the FSP agreement that must be communicated include:

  • The agreement may include the temporary transfer of certain employees knowledgeable about the project to temporarily work with the FSP. This limits the need for new workers to spend time and money to familiarize themselves with the project. When this happens, clear communication with the employees is imperative so they know who is in charge and what the expectations are for everyone on the project. This will relieve the FSP of potential personnel problems and concerns.
  • Plan in advance for contingencies. Anticipate potential problems during the management of clinical trials and establish protocol as to how those problems will be solved. For example, what happens if there is a lull in the workload at the FSP due to a glitch at the pharmaceutical company?
  • The FSP and pharmaceutical company need to agree on the vision for the project to be sure they are both on the same page headed for the same goal.
  • If the project is confidential, this needs to be clearly communicated to the FSP and all employees who will be working on the project.

Need for listening skills
As basic as it seems, communication and collaboration involve listening. When one entity owns the project and the other entity is the chosen vendor for outsourcing, conflict is not uncommon. Experience has shown that while the formal contract outlines the responsibilities of the entities and governs who has the authority, the key to the success of the project is the ongoing communication and the willingness of each entity to listen to the concerns of the other. It is this active communicative relationship that guarantees the ultimate success of the project.

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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.

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(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.

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

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



?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:?

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.?

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

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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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.


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!

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