Fast and Reliable Data for Your First-in-Human Trials
Data gathered during first-in-human (FIH) trials is critical to making go/no-go decisions in drug development. At Altasciences, we provide you with:
- Timely sample analysis and scheduling flexibility
- Rapid turnaround of PK/PD analysis between cohorts (within 48 to 72 hours)
- Excellent communication and information sharing between clinic and lab
- Early proof-of-concept signals
Our focus on early phase research, our integrated preclinical, clinical, manufacturing, and laboratory operations ensure data is shared with full transparency. PK analysis is built into your program schedule from the start, and dosage adjustments can be accommodated for safe and quick
decision-making.
Partner with us to get quality data you can rely on, fast.
You may also be interested in the following:
- Fact Sheets:
- Webpage: Pharmacokinetics/Pharmacodynamics Capabilities
- Podcast: Certificate of Analysis Essentials for Regulatory Bioanalysis
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Tour our Analytical Laboratory
Altasciences’ analytical laboratory services teams support a full range of pharmaceutical and nutritional supplement testing capabilities, as stand-alone or as part of an integrated service offering, including:
- APIs, excipients, and packaging components
- Drug product release and stability testing
- Analytical method development, qualification, and validation
- On-site ICH stability storage and testing
Join our Executive Vice President of Operations, Ben Reed, on an exclusive virtual tour of our state-of-the-art analytical laboratory, and learn about the advanced equipment and techniques used by our scientists to ensure the quality and success of your drug development program.
Want a more in-depth virtual or in-person tour of our 64,000-square-foot manufacturing facility? Request one here.
Questions? Speak with an expert.
You may also be interested in the following:
- Webpage: Pharmaceutical Contract Manufacturing and Analytical Services
- Fact Sheet: Pharmaceutical Analytical Services
- Webpage: Bioanalytical Services
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.
The Key to Selecting the Right Bioanalytical Platform
Trying to select the right bioanalytical platform for your molecule isn’t obvious. Altasciences’ team of scientific experts can help expedite your research goals by proactively advising the best pathway for your unique molecule.
Download this list of key considerations
for selecting the right bioanalytical platform.
You may also be interested in the following:
- Fact Sheets:
- The Altascientist: Microsampling in Drug Development
- Webinar: Quantitation of Passive Immunotherapeutic Agents for COVID-19 by LC-MS
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Evaluation of CNS-Active Drugs for Worldwide Submission
In this complimentary webinar, Dr. Beatrice Setnik and Dr. Andy Mead take a comprehensive look at the key differences between the EMA and FDA drug development requirements when evaluating CNS-active drugs for abuse potential, as well as the need for a controlled substance designation.
Questions? Speak with our scientists.
You may also be interested in the following:
- Podcast: Altasciences' Scientific Experts Discuss Safety Pharmacology
- Webinar: Navigating Early Phase CNS-Active Drug Development
- Fact Sheet: Driving Simulation Studies
- Webpages:
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Ethnobridging Supports Global Clinical Development
In our February 2021 blog we discussed protocol design concepts for ethnobridging in Phase I clinical trials.
High Potency Drug Manufacturing Solutions for Your Program
Altasciences’ CDMO facility is equipped to manufacture and handle highly potent compounds.
- Scalable, segregated, flexible, GMP high potency/Grade C and D clean rooms with dedicated air handling for potent compounds
- State-of-the-art equipment for safe, effective manufacture of your potent materials, from clinical through commercialization
- Formulation and product development
- Multiple dose capabilities
Listen to the podcast to learn more on how Altasciences handles and manufactures highly potent pharmaceutical ingredients, the equipment used, and the rigorous processes in place to ensure your program's success, safely.
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| Ben Reed Executive Vice President, Operations Altasciences breed@altasciences.com |
Shawn J. Connaghan Vice President, Quality Assurance Altasciences sconnaghan@altasciences.com |
Do you have questions? Speak with an expert.
You may also be interested in the following:
- Webpage: Overview of our Pharmaceutical Contract Manufacturing Services
- Video: Altasciences’ Manufacturing & Analytical Solutions
- Video: Benefits of Liquid-Filled Capsule Manufacturing
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.
The Brain on Drugs ― a Discussion with Neuroscientist Dr. Denise Milovan
This on-demand webinar focuses on the importance of including biologic and cognitive pharmacodynamic markers in your early phase clinical trials.
Presenters Dr. Beatrice Setnik and Dr. Denise Milovan unpack:
- Strategic information collected through targeted cognitive markers
- How cognitive endpoints guide the design of clinical trials
- Specialty studies to help make informed clinical development decisions
- Why include biomarkers in early phase trials, including neurology and inflammation
To learn more about our CNS-driven solutions, speak with our experts.
You may also be interested in the following:
- Webinar: The Many Facets of Early Phase Evaluation of Psychedelics in Psychiatry
- The Altascientist: Maximizing Drug Formulation for First-in-Human Trials
- Webpage: Human Abuse Potential Capabilities
- Fact Sheet: Bioanalytical Services
- Video: Altasciences ― Fully Integrated Drug Development Solutions
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Take a Virtual Tour of our State‑of‑the‑Art Bioanalytical Laboratories
From Discovery to Preclinical to Phase IV, Altasciences’ Laboratory Sciences team of over 260 scientific experts specialized in bioanalysis, ligand binding assays (LBA), mass spectrometry, immunology, biomarkers, and PCR, operates in three strategic locations in proximity to our preclinical and clinical sites. We aim to provide top quality data for TK, PK, and PD determinations to support your preclinical and clinical studies.
Our LC-MS/MS and LBA laboratories feature:
- Capacity to analyze over 60,000 study samples per month
- Designated containment level 2 areas for risk group 2 pathogens
- State-of-the-art instrumentation
- SCC GLP accreditation
- On-site 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our bioanalytical laboratories or contact us for more information.
You may also be interested in the following:
- Webpages:
- Podcast: Three Laboratories ― One Vision, with Dr. Lynne Le Sauteur
- The Altascientist: Microsampling ― Applications, Benefits and Considerations
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether for 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.
Have you Considered Microsampling for your ANDA Submission?
Have you seen the recent FDA guidance confirming the possibility of using microsampling for PK sampling in ANDA trials? Please refer to Section 3c, page 11 of the guidance entitled Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.
Altasciences’ leadership and expertise in the field of microsampling is unparalleled, including preclinical collection, clinical collection and self-sampling, and bioanalytical method development using a variety of microsampling techniques and devices.
You may also be interested in the following:
- The Altascientist Scientific Journal: Microsampling
- Fact Sheet: Microsampling in Early Phase Drug Development
- Blog: Leveraging the Benefits of Microsampling for Safety and Convenience
- Video (two minutes): Microsampling
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.
Options and Opportunities for Safety Pharmacology Studies
Help guide the safe performance of clinical trials through design and conduct using thorough data from safety pharmacology studies.
Read The Altascientist Issue 13 – Safety Pharmacology Guidelines and Practices
Efficiencies in time and resources, as well as certain analytical advantages, can be realized by:
- combining safety pharmacology studies (i.e., cardiovascular and respiratory) where appropriate
- including safety pharmacology endpoints in general toxicity studies
You may also be interested in the following:
- Brochure: Safety Pharmacology Capabilities
- Podcast: Altasciences’ Scientific Experts Discuss Safety Pharmacology (10 mins.)
- ICH Guidance for Industry S7A Safety Pharmacology Studies for Human Pharmaceuticals
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.