GUEST COLUMNISTS

• Addressing Disparities And The Democratization Of Clinical Trials

  Advancements of the protocols, tools, and technologies that were highly leveraged during the COVID-19 pandemic are the key to breaking down the barriers that perpetuate clinical trial disparities.

• Best Practices For Implementing Decentralized Clinical Trials

  While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms.

• A Rose By Any Other Name … What Is A CRA Anyway?

  Ask any project team, or CRA for that matter, what the expectations are for this role and you’ll get vastly different answers. For many, the CRA is an all-knowing, all-purpose expert with a broad range of responsibilities. For others, the role is more focused on the monitoring and compliance aspects of study conduct.

• Research Drives Progress In Precision Medicine

  Precision medicine is moving ahead in leaps and bounds in the battle against cancer. Research is continually identifying more biomarkers, leading to promising new treatments. But these exciting new therapies will never happen without a concerted effort from all stakeholders to drive and support clinical trials.

• Tips For Establishing & Maintaining An Effective CRO Partnership

  Strategic CRO partnerships can accelerate timelines, improve efficiencies, enable access to global footprint, and leverage the continuation of corporate knowledge and domain expertise. However, these relationships require constant nurturing and engagement as well as mutual widespread investment between both parties.

• Let’s Tackle The Hidden Real-World Reasons For Poor Clinical Trial Diversity

  To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials. Here, we will pull back the covers on the issues we must tackle to improve diversity in trials. 

• Lessons For Leaders: The Loud And Lasting Impact Of COVID-19 On The Future Of Clinical Research

  Last year, shortly before the pandemic, we predicted that clinical trials of the future would be more open, more human-centered, and more integrated in the healthcare ecosystem, providing guideposts for how industry will adapt along these three themes. COVID-19 has both accelerated these trends and highlighted new challenges for R&D leaders to address.

• ICH E6(R3) – Opportunities For Collaborative Alignment Between Stakeholders On eSource & RWE Priorities

  During the 2020 Avoca Quality and Innovation Summit, an interactive brainstorming system was used during a workshop on ICH E6(R3) to gather industry executives’ insights about guidance that would more rapidly and effectively enable quality adoption of innovative trial designs and technology

CLINICAL TRIAL WHITE PAPERS

• Comparator Local Sourcing For Clinical Trials

  This growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges of sourcing locally, and the circumstances under which local sourcing can be a sound decision. Recommendations are provided for avoiding common pitfalls in implementing a local sourcing strategy.

• Tips For Submitting Expedited Review Studies

  Becoming familiar with the expedited requirements is a good way to ensure you can navigate the review process effectively. Set yourself up for success by reading 6 tips for submitting research studies for expedited review.

• EU GDP Guidelines: Implications For Shipping Clinical Materials Into The European Market

  It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.

• Addressing Cultural Fit With Outsourced Resources: How Can You Find The Right Match?

  In order to make any outsourcing model work effectively, it is essential to evaluate and match both the skill set and the cultural fit of the candidate and sponsor. This article will discuss strategies for finding the best cultural match and the impact it can have on implementing a successful FSP model.

• How Sponsors Can Ovecome The Growing Challenges In Clinical Trial Budgeting And Negotiation

  This paper seeks to explore the most crucial obstacles to successful budget design and negotiation in light of the current complexity experienced across the clinical trial universe. It highlights how technology can streamline these traditionally manual, time-consuming workflows, increase transparency and predictability, and deliver more current, and accurate data for an optimized study start-up.

• The Tale of Two Trials

  The debate surrounding best practices for patient management and data collection during clinical trials is ongoing. In this paper we take an in-depth look at the benefits and drawbacks of the traditional, paper-based outcomes assessment method, as well as the advantages of the emerging electronic clinical outcomes assessment (eCOA) solutions.