April 2017

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DRAFT GUIDELINE ON GOOD CLINICAL PRACTICE COMPLIANCE IN RELATION TO TRIAL MASTER FILE FOR CONTENT, MANAGEMENT, ARCHIVING, AUDIT AND INSPECTION OF CLINICAL TRIALS

A Trial Master File (TMF) is the collection of essential documents that facilitates the conduct and management of clinical trials and allows the integrity of the trial data and the GCP compliance of the trial to be evaluated. A few weeks ago, the EMA published a draft guideline that aims to describe the requirements for a TMF as covered in the new Clinical Trials Regulation (EU) No 536/2014 and ICH-GCP E6. This guideline will assist organizations in maintaining a TMF that facilitates trial management, good clinical practice (GCP) compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and subsequent destruction of paper documentation.

 

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Ask the Experts

Do you have a question about your drug development program or a clinical trial? Get access to some of the industry's leading experts here.

Dr. Brad Vince, CEO and Medical Director, Kansas site

PAIN MODELS

Dr. Brad Vince, CEO and Medical Director at our Kansas site, has extensive experience and expertise in the conduct of complex clinical pharmacology trials in healthy normal volunteers and patient populations.

Altasciences has been engaged in clinical pharmacology studies on pain medication for almost 20 years. The pain models we have tested examine various aspects of pain depending on the target of the compound, such as neuropathy or inflammation. In the past 10 years, our experience has extended to the assessment of parameters for PK and pharmacodynamics (PD) on stand-alone studies and as part of a FIH protocol.

The PD measures we have examined also include abuse liability, cognition, and biological biomarkers.

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Gregory Reid, Director, Medical Science Liaison, Phase I/II at Altasciences

CNS STUDIES

As Director, Medical Science Liaison, Phase I/II, at Altasciences, Gregory Reid is currently assisting drug developers in formulating and executing strategies around FIH and NDA-enabling clinical studies.

Early development clinical trials for CNS drugs are complex and can require in-depth clinical expertise. When conducting CNS trials, it is critical that contract research organizations implement thorough processes in areas such as volunteer eligibility and operational conduct.

Altasciences is a leader in the field of early phase clinical conduct for CNS trials. Our Principal Investigators, Clinicians, Technical Staff, Nurses, and Management Team have an extensive understanding of psychiatric and neurologic disorders stemming from our fifteen-year history of conducting complex studies in various therapeutic indications within CNS.

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VOLUMETRIC ABSORPTIVE MICROSAMPLING

Be sure to check out another great article by Altasciences' Principal Scientist Jeff Plomley to learn how our expertise in Volumetric Absorptive Microsampling (VAMS) technology and the new SCIEX 6500+ LC-MS/MS system are allowing us to implement novel workflows to achieve superior results supporting the critical stage of early phase drug development.

ALTASCIENCES TO THE RESCUE!

What to do when your study needs to be rescued? The goal for a rescue study is quality results at an increased speed. Therefore, rescue studies can be a challenge for any CRO. Thankfully, we are experienced with the critical objectives required for rescuing studies.

RELIABLE DATA IS ESSENTIAL

Every clinical trial's success is heavily dependent on the quality of data generated. At Altasciences, we pride ourselves on our use of state-of-the art technology and our staff's expertise. Both allow us to exceed industry standards and offer exceptional Data Management solutions that deliver clean, accurate and comprehensive data, from start to finish.

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