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Blog Post
Ensuring Successful Enrollment in Oncology Dose Escalation Trials
Oncology dose-escalation trials are a distinct entity, with nuances and considerations which set them apart from other therapeutic areas. From varying trial designs to the patients who participate, dose-finding clinical trials in oncology are a clinical research paradigm. Understanding strategies to facilitate success is key to study planning and execution, from feasibility to site selection through enrollment and treatment.
Blog Post
How Do You Determine the Best Clinical Pharmacology Strategy for Your Product?
Clinical pharmacology is an important cornerstone of the clinical development of drugs, which this blog post has only begun to introduce. Future blog posts will focus on various aspects of clinical pharmacology, including the types of studies that comprise a clinical pharmacology program, a comparison of clinical pharmacology programs for large and small molecules, evaluations of drug interactions, and regulatory considerations for clinical pharmacology.
Blog Post
Data Collection in Decentralized Clinical Trials
Information discussing the transition to DCTs and their challenges, alongside the integration of data collection technology and best practices for sharing DCT data.
Blog Post
505(b)(2) Bridging Studies
While a 505(b)(2) NDA can potentially get a drug to market faster than a 505(b)(1) NDA, the choice of a bridging strategy to the listed drug is important and involves consideration of multiple factors.
Blog Post
Nonclinical Considerations for Gene Therapy Products
The development of a gene therapy (GT) product has many considerations that differ from those of a traditional biologic or new chemical entity (NCE) program.
Blog Post
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
Decentralized Clinical Trials – Looking beyond the Pandemic
A look at Decentralized Clinical Trials (DCT) beyond the pandemic-what we’ve accomplished and where we are heading.
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.
Blog Post
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.