Whitepapers

Dr. Wade T. Iams, MD
Assistant Professor of Medicine, Vanderbilt University

Large, prospective, interventional clinical trials require significant funding and years of development and study execution before practice-informing results are available. There are many critical clinical questions that will never be addressed or addressable through prospective, interventional clinical trials.

Criterium creates configurable electronic data collection tools for efficiently capturing retrospective data that will be submitted for subsequent analysis to answer clinical queries. We work very closely with our clients and have strong ongoing relationships with leading KOL’s & medical experts in our Consortium (ATOMIC), to develop robust e-data capture tools that rely on scripting and revision of very specific and clearly articulated research questions for analysis.

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. Because the TMF confirms regulatory compliance, it is integral to clinical trial success. The success of your TMF starts with effective planning.

We partnered with Montrium, creators of Montrium Connect—a platform for clinical trial document and quality management, to outline 10 Essential Steps for Trial Master File (TMF) Success.

With this whitepaper, you’ll be able effectively plan for your TMF by learning:

• • How to set roles and expectations
  • How to clearly outline processes, maintenance, and tasks
  • What to do when problems arise

By Dr. Jack Macdonald, MD

The large majority of stomach cancer cases occurring around the world are strongly associated with the prevalence of the bacteria H. pylori in populations. The small decrease in gastric cancer incidence we are now seeing may be due to international efforts at H. pylori control.

By Dr. John S. Macdonald, MD

Targeted therapies in oncology are creating positive changes for patients with cancer.

Dr. John S. Macdonald, Senior Consultant to the Oncology Consortia of Criterium, discusses novel treatments and what’s next in oncology research.

• • Read about the New Paradigm in Clinical Research for Targeted Therapies and Immunotherapeutic Strategies
  • Explore Immune Manipulation to Shrink Malignant Tumors

By Lawrence Reiter, PhD

Now, more than ever, all parties need to be extremely practical in their approach to clinical operations and development.

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By Mary Stefanzick

The CDL is a new role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money. A CDL is key in that he or she conducts real-time data review and facilitates centralized control of data management.

The CDL role within a CRO 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.

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By Ronny Schnel, MA

India’s regulatory environment can be puzzling to work through without guidance.

We are familiar with the ins and outs of the India regulatory environment, from our on-the-ground experience of running trials in country.  Let us be YOUR guide:

• • Our easy-to-follow guide walks you through the process step-by-step
  • Get the answers to your questions about the regulatory maze in India