Driving Simulation
With the finalization of the FDA guidance in 2017, driving simulation studies are now required for any drug that may affect cognition. Driving simulation studies are the ideal way to collect data required for the drug label when pre- and early clinical studies show that a drug may cause somnolence or impair cognition. Our experts can design and conduct driving simulation studies to efficiently determine the extent and duration of driving ability impairment.
At Altasciences, we design driving studies to achieve your objectives, leveraging extensive experience across clinical testing of cognitive effects. We partner with Cognitive Research Corporation to use their proprietary driving simulators, nine of which are permanently installed in our clinic. We have performed well over 10,000 simulated drives to date, analyzing the impairment seen at peak exposure and/or the effect seen the morning after evening dosing.
We have a suite of ten simulators on site at our clinical facilities, with space for more than 20 additional, as needed. Professional oversight is provided by fully-certified, in-house driving simulation study specialists.
Consult our general Driving Simulation Fact Sheet
Case Study
Contributed to the market approval of Addyi (flibanserin), a novel, non-hormonal, multifunctional serotonin agonist antagonist (MSAA) for the treatment of hypoactive sexual desire disorder in premenopausal women.
Proof of Concept (POC)
Our comprehensive, integrated proof of concept (POC) study services help you achieve your critical milestones faster. Our experts in the design and conduct of phase I clinical trials will deliver your clinical research efficiently, effectively, and on time. With the research support of regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, you can trust Altasciences with your POC studies. Proof-of-concept studies present unique challenges in both design and conduct. Working with a CRO skilled in both is vital for the success of your Phase I clinical trial program. Altasciences has designed and conducted a wide range of FIH and stand-alone proof of concept clinical trials.
Consult our NDA-Enabling Fact Sheet
Proof of Concept (POC) Study Conduct Expertise
Our clinical pharmacologists perform background research, and consult with research specialists, to ensure we craft the ideal design to meet your objectives, including collaborating with our preclinical colleagues to select the models or biomarkers that translate from preclinical to clinical. Our clinical trial teams capture the endpoints in a consistent manner, training our staff to administer both objective and subjective proof of concept study tests in the exact same way. We also carefully educate participants in what is expected of them during a Phase I clinical trial.
We routinely perform POC clinical research in healthy participants, and leverage our access to a wide range of patient populations for indications that do not have models appropriate in healthy participants. Prior to starting a proof of concept study, our recruiting department produces an accurate estimate of recruitment numbers and timelines. For some indications, we can recruit a large number of patients (i.e., more than 50 patients in areas like diabetes, obesity, and osteoarthritis), while in others, we conduct POC research with smaller groups.
ISSUE NO. 7 — Understanding the Intrinsic and Extrinsic Factors that Alter Drug Exposure and Toxicity
Up Close and Personal with Ingrid Holmes
Ingrid joined Altasciences in 2011, as Vice President of Clinical Operations at the Montreal site, a facility currently housing seven clinical units with 265 beds, and dedicated
Altasciences Contributes to Positive Top-Line Phase I Results for Chronic Cough Drug Candidate
LAVAL, QC, Canada (December 12, 2018) — Altasciences recently completed an important First-in-Human (FIH), Phase I, integrated adaptive clinical trial, including single and multiple ascending doses (SAD and MAD), Project Management, Bioanalysis, and Medical Writing, for sponsor Bellus Health.
Altasciences’ contributions to the positive top-line results were significant. From recruitment of 90 subjects to management of all relevant aspects of this important FIH trial, Altasciences used a flexible and adaptive approach to fully meet the client’s needs. Altasciences’ contributions allowed Bellus Health to make a well-informed decision to proceed with their promising drug candidate for chronic cough.
“We awarded this trial to Altasciences based on their reputation for quality, speed and efficiency, and we were not disappointed. Thanks to their great efforts, we have been able to determine that our compound is safe and well-tolerated, and we are proceeding to the next stage of development without delay. Altasciences’ ability to deliver results efficiently helped us make important decisions to move ahead,” says Dr. Denis Garceau, Senior Vice President, Drug Development, at Bellus Health.
Altasciences conducts hundreds of early phase clinical trials annually. Their vast participant database permits rapid recruitment, and they are constantly refining their processes and offerings to better meet sponsor needs.
“We are very proud of our work on novel compounds at Altasciences, and the fact that we’re able to deliver results in a timely, efficient manner that meets or exceeds our sponsors’ drug development timelines.” says Ingrid Holmes, Vice President, Global Clinical Operations, for Altasciences.
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.
For more information
Julie-Ann Cabana
jcabana@altasciences.com
913 304-4505
ISSUE NO. 6 — Hybrid Medicines and 505(b)(2) NDA Approval Pathways
Hybrid medicines are drugs based on a generic molecule, and have a different route of administration, format, strength, or indication from the original reference product.
They require re-approval for market authorization, partly based
Altasciences Completes Bioanalytical Laboratory Expansion
LAVAL, QC, Canada (November 8, 2018) — Altasciences is excited to announce the completion of their laboratory expansion. The additional space will be dedicated to ligand binding and cell-based assays. Altasciences’ bioanalytical services continue to grow, and the added, state-of-the-art lab area ensures capacity to continue delivering quality bioanalysis solutions to both their preclinical and clinical clients.
The new, larger space, opened for use this week, is fully equipped to respond to increased demand for cell-based neutralization and functional assays for biologics and vaccines. Altasciences now has additional capacity for cell lineage and functional immuno-phenotyping by flow cytometry to support both preclinical and clinical studies.
“The extension of our bioanalytical laboratory ensures that we are equipped to continue providing the excellent bioanalytical services that Altasciences is known for. As demand for our services grows, we are committed to expanding our infrastructure and ensuring our usual, on-time delivery.” stated Marie-Hélène Raigneau, Altasciences’ Executive Vice President, Research Services.
Altasciences’ bioanalytical team consists of more than 100 dedicated scientists in both the U.S. and Canada who provide a comprehensive suite of bioanalytical services, from discovery to preclinical to phase IV clinical support, for both small and large molecules including immunogenicity, biomarker, and PK.
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.
For more information
Julie-Ann Cabana
jcabana@altasciences.com
913 304-4505
ISSUE NO. 5 — Metabolic Disorders (Obesity, Diabetes, NAFLD/NASH) — Updated 2021
Metabolic disorders are conditions that disrupt normal metabolism and the process of converting food to energy at the cellular level.
Procedure for Repeated Ultrasound Guided Liver Biopsies in Nonhuman Primates
Altasciences Completes Acquisition of Preclinical Testing Business and Hires Key Staff
LAVAL, QC, Canada (October 1, 2018) — Altasciences today announced the completion of the acquisition of a preclinical testing business in Everett, Washington. This transaction will support Altasciences’ goal of being a mid-sized CRO that will provide talent and scale to support the preclinical and clinical markets while creating a new outsourcing paradigm for its clients.
"Our vision is to become the first CRO to build a service offering allowing for multiple points of entry that flows seamlessly from lead candidate selection to proof of concept. We now have more than 1,300 staff members in two countries working together to bring our customers the best possible services," said Steve Mason, Executive Vice President, Site Operations, at Altasciences.
Altasciences also confirmed today three key additions to the Seattle team who already boast significant expertise in preclinical testing. Michael Broadhurst has joined Altasciences as General Manager, Preclinical Safety Testing Operations; Francis Douville has joined as Vice President, Operations; and Julie Forget has joined as Director, Toxicology, and will oversee the Study Director group.
“We specifically hand-picked experienced individuals with whom we worked alongside for many years, back when Charles River in Montreal was known as CTBR. It was essential that we hire people that share our culture and values, and particularly our focus on delivering expert guidance with exceptional customer service. In addition, all three hires understand the importance of integrating our services to provide a coordinated outsourcing experience,” explained Chris Perkin, CEO at Altasciences.
These individuals bring many decades of relevant experience and have been specifically selected to add to Altasciences’ toxicology expertise as well as facilitate integration into the Altasciences vision of a full service early drug development CRO. Both the new hires and existing management will play an integral role as Altasciences prepares to further build and integrate large and small molecule safety testing services.
About Altasciences
Altasciences is a forward-thinking, mid-size contract research organization 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, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
For more information
Julie-Ann Cabana
jcabana@altasciences.com
913 304-4505