Newsletter | February 14, 2022

02.14.22 -- FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products

Featured Editorial
Industry Insights
Device Strategy For eCOA: BYOD Or Provisioned?

Which device is better for collecting electronic clinical outcome assessments (eCOAs): a patient’s own device, known as bring your own device (BYOD), or a vendor provisioned device (PD)? The short answer is, “It depends.” By asking the right questions, and understanding and preparing for all the variables, you can help a sponsor successfully implement the modality that increases patient compliance while minimizing missing data and risks to data integrity throughout the life of a study, even a long-term study.

Key Considerations For The Implementation Of Successful Decentralized Clinical Trials

Learn how hybrid and decentralized clinical trials can provide patients the opportunity to participate in a clinical trial and receive a treatment to which they would otherwise not have access.

Incorporating External Control Arm Studies To Support End-To-End Drug Development

External control arm (ECA) studies are being increasingly utilized to supplement the control group in a randomized trial, or to replace the control group entirely. As a result, many organizations are eager to understand the purpose, feasibility, and potential applications for these types of studies as part of their clinical development strategies.

5 Must-Haves In A Contract Packaging Partner

A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship. 

Formulation Strategies To Shorten Timelines For First-In-Human Studies

It is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.

Enabling Fast, Appropriate Drug Product Supply For Phase 1 Trials

Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.

External Controls In Clinical Research (Part I): The Clinical Imperative

To help shed light on data collection and analysis issues for external controls, this paper examines what constitutes external controls and considers the general benefits and risks associated with their use.

DDC vs. EDC: Frequently Asked Questions

Direct data capture (DDC) and electronic data capture (EDC). They sound the same. But when you dig a little deeper, there are fundamental, crucial distinctions that make a significant difference in clinical research workflows, data quality, and timelines. Here, we briefly cover the differences and answer some of the biggest questions we get from clients surrounding DDC.

DTx Clinical Trials And Data Standardization

This paper explores the benefits and challenges of digital therapeutics (DTx) trials and provides recommendations on best practices for data collection and management.

Rapid Launch Of A Phase 1 COVID-19 Vaccine Trial

At the onset of the COVID-19 pandemic response, our current client needed help to kick off a Phase 1 vaccine trial. The sponsor had identified sites and patients and the gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization. Learn how we helped our client design and launch their clinical trial database in two weeks' time, with patient randomization beginning the day of launch.

How To Enroll 612 Patients In A Neurology Study On Time And Within Budget Despite Hurdles Caused By The Pandemic

In the available case study, learn how a leading Indian pharmaceutical manufacturer and an Eastern European CRO launched a Phase 3 neurology study within an impressive seven months.

Strategically Controlling Clinical Trial Costs: 5 Big Takeaways

Ensuring that your trial is delivered with the highest of quality, on time, and on budget is essential with the escalating costs to conduct clinical trials and to avoid unnecessary and often required change orders. This infographic reviews five key takeaways for controlling clinical trial costs while building a focus on quality from the beginning.

Bringing Patient-Centricity And Scale To Decentralized Trials

In the available webinar, explore how decentralized trials (DCTs) have forced the industry to rethink their approach to study start-up and associated regulations.

Reducing Complexity In Starting Clinical Trials

As clinical trials grow more complex, stakeholders urgently need to improve clinical trial efficiencies. Cognizant shared investigator platform (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.

Rethinking Patient Engagement In Oncology Studies Webinar

This webinar describes a new framework for retaining and engaging participants in long-term oncology studies.

Decentralized Trials: How To Develop A Flexible Supply Chain

Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient, and hybrid services utilizing a global GMP depot network.

The Transformation Of Clinical Data Capture And Management

Learn how the rapidly evolving clinical data capture landscape influences the challenges clinical data management teams face, and the emerging technology, processes, and skillsets that can help the industry adapt.


Event overview:


Notifying investigators about serious adverse events that occur during clinical trials is an important requirement that helps protect research participants; however, when the volume of paper and email notifications becomes overwhelming, research sites may lose the clinical relevance of individual events as they struggle to manage acknowledgements and remain compliant.


In this webinar, you’ll learn how IQVIA Technologies (formerly DrugDev) is solving this clinical safety dilemma. The single sign-on, SaaS-based Safety Notifications module of the IQVIA Investigator Site Portal centralizes and simplifies the creation, distribution, and acknowledgement of safety letters for both sites and sponsors. Join us to see how sponsors are eliminating redundancy for their sites across molecules and studies while gaining complete oversight of the safety notifications process.


3 Key Take-Aways:

  • Learn how to eliminate both over-communication and under-communication of safety events to investigators
  • See in action an intuitive safety notifications system that reduces site burden and increases compliance with reporting rules around the globe
  • Understand the value of an integrated data experience that feeds future site selection criteria and enables continuous process improvement
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