After a long wait, the FDA has published a new draft guidance to ensure greater diversity in clinical trials. The guidance outlines how sponsors can create and implement diversity action plans to be more inclusive of underrepresented and minority populations in late-stage clinical trials, though the FDA advises sponsors to develop comprehensive strategies for the entire clinical process, including early-stages. Take a look at the full draft guidance below, which details: • diversity action plan requirements • applicable medical products and studies • submission timing and process • FDA waiver evaluation criteria #FDA #ClinicalTrials #Diversity
Altasciences
Research Services
Laval, Quebec 31,213 followers
Quicker go/no-go decisions with integrated preclinical, clinical, bioanalytical, manufacturing, and CRO services.
About us
Outsourcing made easy with a one-stop solution to early phase drug development. We are an integrated drug development solution company, offering pharmaceutical and biotechnology companies a proven, flexible approach that removes the need for multiple service providers during the early stages of drug development. Whether for one study or an end-to-end program, we help you reach critical decision-making milestones sooner by improving speed and ease from lead candidate selection to clinical proof of concept, and beyond. When partnering with Altasciences, you can experience up to 40% in time savings thanks to our integrated, one-stop solution offering. We strive to create a true partnership with our clients, our partners, and our colleagues that enables a mutually supporting relationship built on a combination of excellent science and solid communication. Helping sponsors get better drugs to the people who need them, faster, for over 25 years. Our full-service offering is always tailored to your specific research needs: - Preclinical research - Clinical pharmacology - Drug formulation - Manufacturing and analytical services - Bioanalysis - Program management - Medical writing - Biostatics - Data management - And so much more!
- Website
-
http://www.altasciences.com
External link for Altasciences
- Industry
- Research Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Laval, Quebec
- Type
- Privately Held
- Founded
- 1992
- Specialties
- Clinical Research, Clinical Trials, Phase I-II, Human Abuse Liability & Abuse Potential, Early Cardiac Safety & TQT, Biosimilars, Bioanalytical Laboratory, Analytical Services, Toxicology Study, CDMO, Safety Pharmacology, Preclinical Study, GLP / Non-GLP Study, IND-Enabling, NDA Submission, LCMS and LBA, Small and Large Molecule Bioanalysis, Research Support Services, Medical Writing, Clinical Project Management, and Pharmaceutical Manufacturing
Locations
Employees at Altasciences
Updates
-
Greetings from Cambridge, UK! Let’s connect, share insights, and drive innovation. #ONHelix24 #Preclinical #Toxicology
-
-
Happy Independence Day to our American followers! Here’s to celebrating freedom with family, friends, food, and fireworks. Enjoy every moment! #IndependenceDay #WeAreAltasciences
-
Biomarker assays are essential as their ability to offer early indications of efficacy and safety significantly accelerates the overall drug development process. Our Laboratory Sciences Division has vast experience developing assays for screening, qualification, or fit-for-purpose validations. We are well-equipped to handle a wide range of biological samples, allowing for comprehensive biomarker analysis across various study types. See available assays here: https://lnkd.in/djYx7PDd Stay tuned, we have more on the way! #DrugDevelopment #Biomarkers #LifeSciences
-
Checking in today from Columbia, Missouri! Follow Larry Karnes as he takes you through a day in the life of a preclinical study director—from desk work and vivarium visits to solving Rubik's cubes and mentoring colleagues. #WeAreAltasciences #DrugDevelopment #PreclinicalResearch
-
Altascientists at all nine of our facilities recently took time to celebrate each other and the important work that we do as your partners. Here’s to many more remarkable accomplishments, and even more reasons to celebrate! #WeAreAltasciences #DrugDevelopment #TeamworkMakesTheDreamWork
-
-
-
-
-
+14
-
-
Thank you Amber Malloy for reminding us. Truer words were never spoken, and this is why we are proud of the work we do. #LifeSciences #FutureOfMedicine
-
-
Happy Canada Day to our Canadian followers! Remember, calories consumed on Canada Day don't count. So go ahead and indulge in all the poutine and butter tarts you desire! #CanadaDay #WeAreAltasciences
-
Go the mile with Altasciences―from discovery to market! Our vast range of oral solid dose manufacturing services includes formulation development, preclinical and clinical material production, as well as scale-up to commercial manufacturing. Our highly trained scientists work closely with you and their CRO colleagues to streamline production procedures and deliver safe, efficient, cost-effective products. Explore our comprehensive suite of drug development and manufacturing solutions: https://lnkd.in/eTvqYtu5 #DrugDevelopment #PharmaceuticalManufacturing #CDMO
-
-
“We have built a one-stop solution for sponsors to seamlessly advance their molecules and help them bring better drugs to patients, faster.” — Marie-Hélène Raigneau, Co-Chief Operating Officer Read on: https://lnkd.in/d5YzBktX Thank you to Pharma Tech Outlook for recognizing us as one of the Top CROs of 2024! #DrugDevelopment #LifeScience #Biopharma
-