Clinical Trials
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.
Take a Virtual Tour of our State‑of‑the‑Art Clinical Laboratories
With over 25 years’ experience in clinical pharmacology, our experts provide comprehensive drug development solutions to get your molecule to clinical proof of concept. Our experienced team can guide you in the design and conduct of your studies in a wide range of therapeutic areas, including small molecules, biologics, 505(b)(2) and hybrid applications.
Combined, our clinical pharmacology units total 130,000 square feet and feature:
- Over 500 beds
- 10 on-site driving simulators
- On-site pharmacies
- Long-term stay facilities
- Upscale amenities for participants
- Outpatient and return units
- Participant screening facilities
- 24/7 security
Catch a glimpse of the facility here.
Request a full virtual tour of our clinical facilities or contact us for more information.
You may also be interested in the following:
- Webpages:
- Webinar: The Strategic Use of Cognitive Measures and Biomarkers in Early-Phase CNS Drug Studies
- The Altascientist: Central Nervous System Active Drugs ― Complex 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.
Don’t Miss it ― a Regulatory Discussion with our Experts
Complimentary Webinar — Clinical Trials in Support of a U.S. Drug Submission
Did you know that first-in-human (FIH) clinical trials conducted in Canada can accelerate regulatory approvals from the EMA and the U.S. FDA?
For an overview of foreign health authority requirements for approval to conduct a FIH clinical trial, including a comparison of Health Canada’s and the EMA’s Clinical Trial Authorization (CTA) processes and the U.S. FDA’s Investigational New Drug (IND) submission process, watch this complimentary webinar.
Topics covered include:
- Ensuring timely FIH clinical trials when planning your early phase drug development strategy
- Utilizing foreign clinical trials for U.S. FDA drug submissions and approvals
- Differences in the quality and nonclinical data submission requirements to gain EMA, FDA, and Health Canada approval to conduct FIH trials
Contact us to discuss the additional benefits of conducting FIH trials in Canada.
You may also be interested in the following:
- Webpage: Scientific, Regulatory, and Strategic Guidance
- Fact sheet: Clinical Sample Collection Kits
- Fact sheet: First-in-Human (FIH) Studies
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.
Small Molecule, Nonclinical Drug Development Solutions
As your drug development partner, we have a deep appreciation of both the challenges and the potential of your small molecule. At Altasciences, we understand why developing your molecule requires tailored solutions at every stage.
Find out how our small molecule solutions help identify new and improved approaches to study designs, and anticipate development challenges as studies evolve.
Bring us your challenge. We have the solution.
You may also be interested in the following:
- Factsheet: Small Molecule Safety Assessment
- IND/CTA Guide: Planning your Preclinical Assessment
- Webpage: Bioanalytical Services
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.
Data Management Excellence – What it Takes
What Data Managers Do
Gathering, analyzing, and presenting the data to support life-altering new medicines for people around the world is a long, complex, and detailed proces
The Lancet Covers Altasciences’ Contribution to Research for Weight Management
A Look into Weight Management Research
Altasciences’ Medical Director and Investigator, Dr. Martin Kankam, M.D., PhD, MPH, along with a team of scientific experts, have successfully investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide 2•4 mg for weight management, in a randomized, controlled, Phase Ib trial.
Access the full article co-authored by Dr. Kankam to learn about the findings, methods, and results of this trial.
As experts in the field, we have conducted over 75 early stage trials involving antidiabetic and hypoglycemic agents in patients who are diabetic (Type 1 and 2), obese, or have metabolic syndrome or NASH. These include a large number of proof-of-concept studies investigating different measures of glucose tolerance, including clamping studies using the state-of-the-art YSI 2950D biochemistry analyzer to efficiently process multiple glucose samples per run.
Speak with a metabolic disorder expert today.
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.
You may also be interested in:
- The Altascientist: The Global Challenge of Metabolic Disorders
- Fact Sheet: First-in-Human Capabilities
- Webpage: Proof-of-Concept Capabilities
- Press Release: Altasciences Qualifies Quantitative Serological Assay for the Detection of SARS-CoV-2 IgG Antibodies
- Press Release: WCCT Global (an Altasciences Company) Clinic Expansion
Effect of Difelikefalin, a Selective Kappa Opioid Receptor Agonist, on Respiratory Depression: A Randomized, Double-Blind, Placebo-Controlled Trial
Seamless Transition from Clinical Study Sample Collection to Bioanalytical Analysis
We are your single solution for both clinical conduct and bioanalytical analysis. Partner with our scientific experts to seamlessly make your critical go/no-go decisions… and save both time and money.
We make the process smoother by:
- Dedicating a team of scientific experts who are best equipped to walk you through every step of your project’s development
- Using one integrated sample management system, Watson LIMS™, from study sample collection to bioanalytical analysis
- Providing rapid in-house study sample shipping from our clinical site to our bioanalytical labs
- Eliminating time loss for the reconciliation of samples
- Ensuring timely PK analysis of safety data needed for critical, key decision making for later stage studies
Need we say more? Start saving time, contact our experts today.
You may also be interested in the following:
- Fact sheets:
- Webpage: Tell Us Once™
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.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica