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Analytical Method Quality Throughout the Pharmaceutical Development Lifecycle

For a drug to be used in a human clinical trial, analytical testing must be performed to demonstrate the suitability of the drug for use. These tests ensure the identity, quality, strength, purity, and potency of an active substance and drug product or biologic and must be scientifically sound and validated to demonstrate their suitability for the defined use.

Blog Post

Estimands: An insight into the new framework

An estimand framework has been presented by the ICH in November 2019 and the FDA in May 2021 to provide clarity on defining the reported treatment effect. This blog post summarizes the key components to the estimand framework that are covered in the ICH E9 (Revision 1) addendum on estimands and sensitivity analyses in clinical trials, as well as the supporting FDA guidance and ICH training material.

Blog Post

5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

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CMC Activities for a 505(b)(2) Development Program

While a 505(b)(2) NDA can help a drug get to market faster, the time to complete the CMC activities cannot be overlooked, and the quality data package that is required in the marketing application must be incorporated in the overall project timeline.

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Inspection & Audit Preparation in Decentralized Trials

To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.

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Data Integrity Considerations in Decentralized Trials

Collected data from DCTs need to be integrated with other data captured during the course of a clinical trial, and data integrity must be ensured in the absence of source data verification. Two topics will be discussed: how to manage this integration and ensure confidence in the collected data.

Blog Post

Protocol Planning and Design for Quality Decentralized Clinical Trials

Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?