November 2016

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Industry News

Draft guideline on strategies to identify and mitigate risks for first‑in‑human and early clinical trials with investigational medicinal products

On November 10th, the European Medicines Agency followed through on plans to update its guidance on first-in-human clinical trials. 'The revision is intended to further assist sponsors in the transition from non-clinical to early clinical development and identifies factors influencing risk for new investigational medicinal products (IMPs). The document includes considerations on quality aspects, non-clinical and clinical testing strategies and designs for first-in-human (FIH) clinical trials (CTs) and early phase CTs (see section 2). Strategies for mitigating and managing risks are given, including principles on the calculation of the starting dose to be used in humans, the subsequent dose escalation, the criteria for maximum dose and the conduct of the CT including the conduct of multiple parts.' Consultation ends February 28, 2017.

 
VIEW THE DRAFT GUIDANCE

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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.

Pascal Guibord, Senior Director of Biometrics at Altasciences

CDISC STANDARDS

Pascal Guibord, Senior Director of Biometrics at Altasciences, is fully versed on the Requirement for Standardized Study Data guidance that states that all clinical trials beginning after December 17, 2016 must be submitted to the FDA in the CDISC format.

Click below to find out how we can help or to ask a question of Pascal.

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

BIOSIMILARS

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 with biologics and biosimilars.

Click below to learn about the requirements for trials for biological products or to ask a question of Dr. Vince.

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BIOANALYSIS CASE STUDIES

Kevork Mekhssian, Principal Scientist, Method Development, presented the following case studies at the 9th EBF Symposium: Quantification of the Growth Hormone Receptor Antagonist Pegvisomant by LC-MS/MS in Rat Plasma and Development of a Multi-Peptide IC-LC/MS Assay for the Quantitation of a PEGylated Therapeutic in Rat and Dog Plasma.

RESCUE STUDIES

When your trial needs a lifeline to get it back on target, time is of the essence in order to expedite key milestones. Our clinics can be ready for First Patient First Visit within 8 days. If you're ready, we're ready.

DRIVING SIMULATION VIDEO

We have partnered with Cognitive Research Corporation (CRC) to provide sponsors with a state-of-the-art driving simulator study solution to test the impaired effects of a wide variety of drugs on driving abilities in both normal and patient populations.

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VIEW THE VIDEO
 

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