Newsletter | April 28, 2021

04.28.21 -- Solving The Top 5 Challenges Of Decentralized Trials

Featured Editorial
Industry Insights
Decentralized Clinical Trials: Are They Here To Stay?

In 2020 the clinical trial industry adapted and responded in rapid fashion. Measures were taken to allow for continuity of studies, all while shortening timelines and ensuring safety and flexibility of care. This flexibility can be seen through trial decentralization — enabling care to be continued through varying methods, whether bringing care to the patient’s home, allowing patients to benefit from local labs, or utilizing technology to complete trial requirements. This response by the industry was impressive and perhaps provides a glimpse into the future of clinical research. But what does the future look like?

Reaching The Trial Master File (TMF) Health Zone: Expert Guidance From The TMF Authority

Over the past 12 to 18 months, regulatory agencies have been increasing their focus around the trial master file (TMF) and tightening their enforcement. In this white paper, we have summarized this extensive knowledge into core principles to provide pragmatic guidance on how to best reach the TMF health zone.

Leveraging A Central Institutional Review Board (IRB) Office To Improve Turnaround Times And Consistency

Utilizing a centralized institutionalized review board (IRB) office, supported by Advarra’s Center for IRB Intelligence Platform (CIRBI), the Academic and Community Center Research United (ACCRU) research network improved their review turnaround times by weeks and increased review consistency. Leveraging central IRB elements such as state-of-the-art technology, a single point of contact, and a centralized location for all study documents and approvals ensured a smooth transition process.

Accurately Aligning Data Structures That Can Stand Up To Regulatory Scrutiny

A biopharmaceutical company had an ongoing observational study with 120 patients in five sites. As the team started to plan their first Phase 1 study they realized that they wanted to align the data structures from both studies. By applying previous experience of rescue approaches for clinical data, Cmed built an encapsia database to meet the needs for all the prospective data.

Safely Transporting Medicines To Patients

Do pharma companies underestimate supply chain challenges? Much can go wrong when sending a therapy from A to B, but the right collaborations can mitigate risk.

Designing An Optimal APAC Clinical Supply Chain

With clinical study activity increasing in the Asia-Pacific (APAC) region, it is important for sponsors across the globe to understand the area landscape to develop a distribution strategy that avoids delays and minimizes cost and risk. Learn how to navigate complexities throughout the region.

An Illustrative Guide To Clinical Trial Design In The Era Of Cloud Computing

The mere availability of complex innovative trial design methodologies cannot translate into higher success rates in regulatory submission or approval if the process that drug development teams use for statistical design remains unchanged. Advanced technology now enables leaders to actively facilitate process improvements. Cytel’s new infographic demonstrates the combination of technology and design process advances required to unify statistics with commercial strategy.

Are The Intended Benefits Of ICH Regulations Obscured By The Adoption Struggle?

ICH E6(R3) is coming at a time when organizations are struggling to adopt ICH E6(R2). But should organizations wait until these guidelines are ratified to realize the intended benefits? What are the benefits from implementing ICH regulations now? And is change management the greatest challenge to overcome in the adoption struggle? View this webinar to help answer these questions.

LSX 2021: The Path From Preclinical To And Through Clinical

Originally presented at the 2021 LSX World Congress virtual conference, this webinar series by Premier experts in oncology, rare disease, and cell and gene therapies focuses on development considerations for advanced therapies, highlighting these products’ unique challenges as well as their powerful potential to address a broad array of unmet patient needs.

Reducing Complexity In Starting Clinical Trials

As clinical trials grow more complex, stakeholders urgently need to improve clinical trial efficiencies. Cognizant SIP solutions for virtual monitoring, study oversight, and document exchange and collaboration, together with Oracle’s study start-up workflows and predictive analytics capabilities, enable sites, sponsors, and CROs to adapt to the new normal of conducting clinical trials virtually.

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