ISSUE NO. 26 — CDISC Data Standards
The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.
In Issue 26 of The Altascientist:
- Introduction to standardization and its benefits
- Client considerations for nonclinical and clinical data standardization Case Study — Realized Efficiency
- Case Study — Realized Efficiency
- Case Studies — Legacy Data Conversion
- The future of CDISC and data strategy
Five Reasons to Place Early-Phase Clinical Research in Canada
A well-planned clinical program designed to meet the regulatory requirements for the jurisdictions where you plan to request market authorization can be conduct
Insights Care: Chris Perkin — A Forward Thinker in the Research Space!
Five Lesser-Known Uses for PCR
PCR testing has been in the spotlight as the most reliable way of screening for COVID-19 in patients since the beginning of the pandemic. But what is PCR? And what are its other uses?
Up Close and Personal With Marie-Hélène Raigneau, MBA, President
Marie-Hélène has been a leader in the drug development industry for close to 20 years.
ISSUE NO. 25 — Flexibility in Phase I Study Timing
The structure of an early-phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase I do not have to be conducted before Phase II commences. Conversely, some studies that are typically done in Phase II can be advanced into a Phase I combined protocol to have access to key data earlier in the program. Early Phase I studies have become increasingly complex in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and helps solidify the overall plan around sound data.
In Issue 25 of The Altascientist:
- Timing of early clinical pharmacology studies
- Phase I combined protocols
- Special populations
- Resource allocation
- Examples of flexible Phase I study timing
Endpoints News: Canadian CRO Altasciences Kicks Off Client Manufacturing Expansion in Philadelphia
ISSUE NO. 24 — Shortening Drug Development Timelines with Asian Ethnobridging Trials
Conducting ethnobridging studies locally, during Phase I clinical trials, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.
In Issue 24 of The Altascientist:
- The importance of Asian ethnobridging in clinical research
- Bridging requirements per the ICH E5 Guidance
- Strategic program considerations per the ICH E7 Guidance
- Accelerating Asian drug development
- Language requirements for global clinical trials
- Altasciences’ expertise and experience with ethnobridging
Future Science: Diversity and Inclusion in the Bioanalytical Industry — An Interview with Anahita Keyhani
Test Your Knowledge of Liquid-Filled Capsules
Thanks to updated screening methods and bioavailability enhancements, poorly soluble molecules comprise 70% to 80% of the small molecule products entering the drug development pipeline today. Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution.