Comparing Cytokine Data to In-Life Parameters on Nonhuman Primates in Nonclinical Toxicology Studies
Rapid Development of a Liquid-filled, Hard-Shell Capsule Formulation of Cannabidiol
The Advantages of Liquid-Filled Capsules Over Tablets in All Phases of Drug Development
ISSUE NO. 23 — Robust Sample Management for Reliable Study Results
The quality of study data depends on a rigorous sample management process that safeguards the integrity of samples at every step, from initial specimen collection through bioanalysis, to post-study storage. A CRO partner that conducts both preclinical and clinical studies, and supporting bioanalysis, ensures continuity of processes, knowledge sharing, and a centralized location for long-term storage of all your samples.
Issue 23 of The Altascientist provides a deep dive into:
- sample collection and storage conditions
- standardized workflows for risk Management and chain of custody
- stability testing
- laboratory management
- customized processes
- management of bioanalytical matrices
- post-study sample management
Why Does Sample Management Matter?
The proper handling of specimens (obtained from the trial participant) and samples (prepared for lab analysis), and their precise, timely treatment is crucial for reliable, robust data, and good decision making. When making a go/no-go decision for a new therapeutic, there must be certainty that the data which informs the decision is of the highest accuracy.
At both the bioanalytical site and the clinical site, meticulous workflows for safeguarding samples must be in place. Careful recording and storage of the samples, according to the study protocol and all relevant regulations and guidelines (e.g., GLP, GCP, ICH), is integral to the successful collection and analysis of trial data. Well-trained staff, managed by a dedicated bioanalytical Principal Investigator with a clear mandate to safeguard the integrity of the data, is a valuable asset.
Sample Collection and Storage Conditions
Preclinical studies and clinical trials can involve many different sample types, in a variety of storage containers. The sample containers for storage below -80 °C are specially developed with materials that retain their integrity under such conditions—a plastic cap that can be refrigerated may not withstand temperatures below -80 °C. Likewise, the container for a different type of sample and temperature will have its own qualities, specific to the situation. The necessity for adding stabilizers, anticoagulants, or other preservatives, either after collection or before bioanalysis, also varies depending on the specifics of each trial.
A comprehensive sample collection manual should be provided to the trial sites, detailing every requirement to ensure that all study personnel are fully proficient at maintaining specimen integrity. Flexibility to accommodate many variables with an equally rigorous workflow, and a readiness to learn and adopt the latest technologies, are key to a comprehensive sample management system that adapts to every sponsor’s needs.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Five Facts About Psychedelics for Mental Health
As the incidence of mental health issues increases around the world, most recently exacerbated by the COVID-19 pandemic that has pushed depression to nearly triple the rate
Q&A: Setting Up Your Clinical Research for Success, With Dr. Nicole Maciolek
Tying together the phases of your drug development program are the essential research support services that help your drug candidates not only meet their milestones, but also regulator
Parallelism Challenges When Using Commercial Kits for Biomarker Quantitation
Altasciences Receives 2022 CRO Leadership Award in Five Categories
Laval, Quebec, May 30, 2022 – Altasciences announced today that it has been awarded a 2022 CRO Leadership Award in five categories, marking the seventh year the CRO/CDMO has been deemed a top performer by Clinical Leader and Life Science Leader.
Each year, Clinical Leader and Life Science Leader team up with ISR Reports to determine award recipients by assessing 50 CROs on more than 20 performance metrics in ISR’s annual Quality Benchmarking survey. This year, Altasciences received awards in the following categories: Capabilities, Compatibility, Expertise, Quality, and Reliability.
“Selecting the right CRO can make or break your project,” says Ed Miseta, Chief Editor for Clinical Leader. “It can lead to a successful regulatory submission and approval or cost you a lot of time and effort on a failed study. That makes CRO selection a stressful decision for any clinical operations manager. We believe our CRO Leadership Awards will help managers with their search process and hopefully help to connect them with the right contract partner. These award winners have proven themselves to be the top service providers in each category. I congratulate all of them for work ethic they exhibit in consistently meeting the needs of their drug development clients.”
Altasciences recognizes the importance of consistently exceeding the standards for excellence set by others in the industry, as well as their own. For more than 10 years, Altasciences has been transforming the traditional outsourcing paradigm, building a one-stop outsourcing solution that simplifies and accelerates the early phase drug development process for our partners. To that end, Altasciences is proud to have exceeded the expectations of small to large pharmaceutical companies, and will use the awards as further motivation to support educated, faster, integrated, and more complete early drug development decisions for their partners.
“To be recognized by the industry is not only an honor but a testament to the expertise of our people and the utmost care they show for both our partners and for those who seek the therapies we help develop,” says Chris Perkin, CEO at Altasciences. “To be acknowledged is a point of pride for our company, yes — but more importantly, it serves as a reminder that the more we build on our Capabilities, Compatibility, Expertise, Quality, and Reliability, the more our solutions can help our clients transform lives around the world.”
About Altasciences
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
CONTACT:
Julie-Ann Cabana
Altasciences
514 601-9763
jcabana@altasciences.com
The Impact of Social Factors on Drug Development
Drug development exists within the context of interrelated social factors that impact its norms and practices.