Clinical Trials
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.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Concomitant Administration of Multiple Doses of Cagrilintide With Semaglutide 2-4 mg for Weight Management
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
Protocol Design Concepts in Phase I Ethnobridging Clinical Trials
In Phase I ethnobridging clinical trials, there are three primary protocol design concepts utilized.
Premier Service Provider for Driving Simulator Clinical Trials
With over 13,000 simulated drives to date and the ability to accommodate up to 20 driving simulators on-site at once, Altasciences is the ideal full-service provider for your driving simulator clinical trials.
You can gather accurate driving performance data comparable in sensitivity to over-the-road testing, with faster study startup, lower cost, no risk of property damage, and no risk of injuries.
When working with Altasciences, you benefit from:
- A large database of study participants for ease of recruitment
- Professional oversight by fullycertified, in-house driving simulation study specialists
- Advanced 3D graphics that generate realistic representations of driving environment
- Automated measurement of psychomotor functioning, divided attention, situational awareness, and other cognitive behaviors
Click here for more in-depth information about our driving simulator capabilities, or contact our experts to discuss.
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.
You may also be interested in the following:
The Altascientist: FDA Finalizes Drug-Impaired Driving Guidance
Video: Driving Simulation Studies
Fact sheet: Driving Simulation Studies
Clinical Applications of Hallucinogens, Dissociatives and other Schedule I Drugs
Following an initial period of study, mainly in the early 20th century, many hallucinogenic drugs had been dismissed as drugs of abuse with no clinical utility.
Podcast — Altasciences’ Clinical Trial Monitoring
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Altasciences’ clinical trial monitoring solutions will help progress your study from initiation to final close-out efficiently, while saving you time and costs. Our team of highly experienced, well-trained CRAs, will work with you throughout the conduct of your clinical trial to ensure strict adherence to protocol and regulations, subject safety, and accurate visit reporting. Learn more about the benefits of working with Altasciences’ CRAs for your clinical trial monitoring needs. |
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Video — A Seamless CRO Experience
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At Altasciences, our integrated, full-service solutions from lead candidate selection to clinical proof of concept are all customizable to your specific needs. Watch as Ingrid Holmes, Vice President, Global Clinical Operations, discusses how we help sponsors bring better drugs to market, faster. |
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Contact our experts to learn more about our integrated drug development solutions. |
Identifying Appropriate Outcome Measures and Methodology to Evaluate the Abuse, Misuse, Dependence, and Impairing Effects of CNS-Active Drugs in Healthy Volunteer and Patient Trials
Data that Meets Regulatory Guidelines Worldwide
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Robust planning early in drug development can save you both time and money. Altasciences' in-house pharmacokineticists and biostatisticians can work with you to build a robust strategy from the get-go. They are accustomed to managing complex projects with different partners, no matter the therapeutic area — your drug will be in expert hands. | |