Featured Editorial
Best Practices In Selecting A CRO
 
By Erin Harris, editor in chief, Cell & Gene

When it comes to partnering with a contract research organization (CRO), many pharmaceutical and biotech companies, particularly small ones, have no choice but to outsource. From crafting clearly defined policies and procedures to establishing non-negotiable requirements of a CRO partner, sponsors select CROs meticulously and judiciously. I caught up with Bob Paccasassi, VP of quality and compliance operations, and Mandy Clyde, VP of operations, at BioRestorative Therapies, for their insight on the best strategies for partnering with a CRO. Here’s what they had to say.

Preparing For Health Authority Inspections: 4 Keys To Inspection Readiness
By Megan Marshall and Maryann Badala, Halloran Consulting Group

Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full-on panic mode. While preparing for an inspection will never be a carefree and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.

Industry Insights
Practical Considerations For Patient-Focused Data Collection In Oncology Trials
Article | By Celeste Elash, YPrime

Read how new initiatives reinforce the importance of the patient’s voice, acknowledge the limitations of traditional approaches, and build on the lessons that emerge from each new study.

Real-World Evidence: Explaining The Current State Of The FDA’s RWE Program
Article | By Paul Roma, Ciox Health - Life Sciences

This article will guide you through the FDA’s real-world evidence (RWE) program and what it means for drug developers and explains the potential real-world data offers in developing real-world evidence to significantly and safely accelerate the drug approval process.

Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.
White Paper | By David Shoemaker, Genna L. A. Kingon, Ph.D., RAC, Kathleen Candando, Ph.D., and Kevin Barber, MS, Ph.D., RAC, PMP, Rho

The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

Study Start Up Solutions Improve CRO Oversight Through Collaboration
White Paper | Oracle Health Sciences

The relationship between sponsors and contract research organizations (CROs) is strengthening as outsourcing becomes a clinical trial mainstay. Making this connection as productive as possible means continuing the transition away from tactical projects and toward strategic partnerships where both stakeholders have a vested interest in greater operational efficiency.

Predictive Biomarker Signature Characterization
Case Study | Cytel

A client was developing a new drug for complex neurodegenerative disease in preclinical development. The drug may be only effective for a particular subgroup of patients. They needed to generate a hypothesis on the molecular pathway and the targeted drug activity and identify a biomarker signature defining potential response to the new drug. Read how Cytel’s analysis produced a biomarker signature that was provided to the client for in-vivo validation.

Development Of Qualified Cold Chain Solution For Vaccine Transport To Uganda
Case Study | Thermo Fisher Scientific

Maintaining the cold chain is a challenge when handling biologics such as vaccines, particularly when the clinic is in a remote location. Learn more about how Fisher Bioservices developed a qualified cold chain solution to transport Ebola vaccines to Uganda.

Global Perspectives On Patient Engagement
Podcast | DIA

Jan Nissen, vice president of patient innovation for Merck & Co., Inc., joins Deborah Collyar, global forum patient engagement co-editor and founder of Patient Advocates In Research (PAIR), to discuss the importance and value of engaging patients in innovative research and product development at our DIA 2018 Global Annual Meeting.

Sponsor
 

The 9th Trial Master File Summit, taking place January 21 to 23 in Orlando, FL, offers attendees premier networking opportunities, access to the trial master file (TMF) community, and endless amounts of critical information to bring back to their teams. Summit participants return to work informed, equipped, and inspired to guide their organization’s TMF to its full potential! Register today and save 15% with discount code TMF20CL.

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