Newsletter | July 22, 2019

07.22.19 -- How Idorsia Pharma Used A Platform Approach To Simplify Workflow

Featured Editorial
A Platform Approach Simplifies Clinical Workflow For Idorsia Pharma
By Ed Miseta, chief editor, Clinical Leader

Idorsia Pharmaceuticals Ltd was founded in June 2017 and came about as a result of the acquisition of Actelion Pharmaceuticals by Johnson & Johnson. Transition agreements allowed the company to use legacy systems from the prior company for a period of 18 months. By the time the agreements expired, Idorsia would have to design its own systems landscape.

A Tactical Approach To Risk Management At The System Level
By Megan Brickley, Halloran Consulting Group

Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type of practice — which is then filed away, never to be utilized again.

Industry Insights
Avoid Enrollment Pitfalls: Find Your Best-Fit Clinical Trial Sites
Article | By Seth Nelson, WCG

Five characteristics to look for when finding the best-fit site for your study.

Patient-Centric Trials: Overcome Enrollment Challenges By Putting Patients First
White Paper | By Wayne Bowden and Kurt Gehlsen, Ph.D., Biorasi

Just as patients have a stronger voice in today’s healthcare marketplace, that voice should resonate earlier in the drug development process. By adopting a patient-centric approach during protocol design and in day-to-day study management, sponsors can expect improved patient enrollment and retention, as well as a cleaner study with definitive outcomes.

Simplifying CRA Reconciliation: 5 Ways To Improve Site Visits
Article | TransPerfect

CRAs are tasked with making sure all documentation and data is as it should be: current, compliant, and following the study protocol(s). Read how, with cloud-based web and mobile eTMF solutions, CRAs can throw away their spreadsheets and experience process improvements.

Emerging Pharmaco’s Dilemma: Make A Deal ... Or Not?
White Paper | IQVIA Biotech

Take a closer look at funding strategies for companies launching products for the first time. Does partnering or "going it alone" make more sense for emerging companies? Read the findings of a 2006 to 2015 analysis, including implications for research companies, their potential large pharma commercialization partners, and venture capitalists.

Drug Safety And Product Protection Driving Blister Packaging Growth
White Paper | Ropack Pharma Solutions

Trends in the packaging of prescription and over-the-counter drugs indicate continued growth in the blister packaging market. 

Harnessing Effective Cold Chain Capability To Absorb The Impact Of Midstudy Protocol Changes
Case Study | Almac Group

The most successful clinical trials have one thing in common: sponsors never stop looking for ways to improve processes that support the core objective of delivering safe, compliant investigational product to patients, when and where they need it. Learn how one sponsor effectively managed a drug formulation change midtrial without study interruptions or patient impact.

Custom Software Enhances Decision Making
Case Study | Cytel

AstraZeneca needed a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features.

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