About Altasciences
25+ Years’ Experience Conducting Early Phase Drug Development
One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral.
Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.
We facilitate drug development and save you time by:
- Preparing your preclinical study designs, including species selection and dose level determination.
- Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
- Writing your IND/CTA applications.
- Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
- Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
- Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
- Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
- Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.
Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.
Speak with our experts.
You may also be interested in the following:
- Video: Your Road to Proactive Drug Development with Altasciences
- Webpage: Scientific, Regulatory and Strategic Guidance
- Webpage: Full-Time Equivalent (FTE) Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Q&A Session with Dr. Danielle Salha
Renowned for our full-service offering, we often get asked — how does Altasciences manage the development process for biologics and biosimilars so seamlessly from the require
Up Close and Personal with Dr. Gaetano Morelli, MD
Dedicated to Medical training
He is a member of the Collège des Médecins du Québec, a Fellow of the Royal College of Physicians of Canada, certified in Internal Medicine and
Prioritizing the Compassionate Care of Research Animals
The 3Rs of Animal Research
The 3Rs philosophy is the guiding principle for the Animal Welfare Program at Altasciences.
2020 Year in Review
2020 has been quite a year! Each year, we strive to provide you with a more innovative, simplified, and seamless early phase drug development journey. And the past 12 months have been no exception.
Up Close and Personal with Dr. Lynne Le Sauteur, PhD
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Dr. Saving You Time With Tell Us Once™
Video — A Seamless CRO Experience
Study Site Management: Eight Reasons to Choose Altasciences
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An important consideration in choosing a research partner for your drug development programs is their experience and expertise in managing their study sites. Get Up Close and Personal with Dr. Anahita Keyhani, PhD
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Dr. Anahita Keyhani is Altasciences' Senior Director of Scientific Operations, Mass Spectrometry and Method Development. |
