COMPLIANCE, TRANSPARENCY, & CLINICAL TRIAL DISCLOSURE
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PLAIN LANGUAGE SUMMARIES OF STUDY DESIGN & CLINICAL TRIAL RESULTS
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DOCUMENT REDACTION
We can assist your team in redacting protocols and statistical analysis plans and authoring anonymization reports.
CLINICAL TRIAL REGISTRY SUPPORT
After assessing current levels of compliance on clinicaltrials.gov, EudraCT, and other registries, our team can work with you to prepare a plan, complete and update entries, and maintain full compliance moving forward.
CLINICAL TRIAL TRANSPARENCY & DISCLOSURE
Increasing clinical trial disclosure requirements, including those announced by the EMA, EFPIA, and PhRMA
PATIENT ADVOCACY
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PATIENT ADVOCATES IN RESEARCH (PAIR) SUPPORTS PLAIN-LANGUAGE SUMMARIES
Publishing both positive and negative results builds trust and goodwill. The publication of each new summary helps to set expectations and share real-world implications.
SOLUTIONS
Your satisfaction is our #1 priority. We'll do what it takes to find the best solution.
Transparency Quotes
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Fundamental Openness
"Transparency is honesty, openness, and integrity. It is fundamental to build trust on everything that matters." --Frank Albers, Global Medical Affairs, Respiratory, GlaxoSmithKline (MPIP website)
Publishing All Data
"Transparency means publishing medically important clinical data in a timely, objective, accurate, and balanced manner, regardless of the outcome of a trial." --Carolyn Hustad, PhD, Executive Director, Global Scientific & Medical Publications, Merck & Co., Inc.
Honoring Study Participants
"Responsibly sharing clinical trial data advances the science that is the foundation of medicine while also honoring the participants who have of themselves to make a difference in the lives of others around the world now and in the future." --Joanne Waldstreicher, MD, Chief Medical Officer, JNJ (MPIP website)
Trust
"Transparency is the currency of trust." --Freda Lewis-Hall, MD, EVP, and CMO, Pfizer, Inc.