Altasciences Clinical Services
For your early phase clinical studies, our experts in the design and conduct of clinical pharmacology and early efficacy studies ensure the data generated meets your objectives — working with you to leverage preclinical data in the design of the studies that take your programs through to proof of concept. Our expertise covers all the clinical pharmacology studies required for regulatory submissions across a wide range of therapeutic areas, covering small molecules, biologics, and 505(b)(2) or Hybrid applications, on behalf of biopharmaceutical companies of every size.
For your early phase clinical studies, our experts customize our process to suit your needs—working with you to leverage preclinical data in the design and then conducting the testing that takes your programs up through proof of concept. We conduct a wide range of study types on behalf of biopharmas of every size.
- 600 beds
- 250+ clinical trials completed annually
- 365K+ participants in our combined database MORE INFO
TYPES OF CLINICAL STUDIES
First In Human (FIH)
A great place to start your early clinical development is with a first-in-human (FIH) study conducted by Altasciences. Our recent experience includes more than 200 FIH studies for both small molecules and biologics.
Proof of Concept
Altasciences can help get an early signal of proof of concept for your new molecule or formulation, given our years of experience in capturing objective and subjective measures, from biomarkers to assessment of signs and symptoms.
With more than 10,000 simulated drives, we have extensive experience designing and conducting driving simulation studies to establish extent and duration of drug-related impairment, or to demonstrate an improvement in driving ability after pharmaceutical treatment.
Human Abuse Potential
Studies looking at human abuse potential and abuse-deterrent formulations require specialized pharmacies, highly trained staff, robust patient databases, and the operational skill to retain participants.
Altasciences has designed, conducted, analyzed, and reported on more than 1,600 bioavailability (BA) and bioequivalence (BE) studies for more than 1,200 products or combinations.
Drug-drug and drug-alcohol interaction studies are important steps in finalizing the clinical pharmacology details of your product label. Trust your DDI and drug-alcohol studies to a CRO that has been designing and conducting them for decades.
Pharmacokinetics in Special Populations
We can rapidly recruit a broad range of special population participants for PK studies, using a combination of our existing database and participant outreach.
We have been designing and conducting QT studies since the FDA E14 guidance was finalized. Altasciences has experience in both early cardiac safety assessment and thorough QT prolongation studies.
RENAL AND HEPATIC IMPAIRED
Renal and hepatic impaired studies are often part of the last set of clinical pharmacology studies needed for regulatory approval. Plan ahead with Altasciences to keep you moving seamlessly toward approval.
Altasciences has the experience and affiliated facilities to incorporate imaging into most clinical pharmacology studies.
Biologics / Biosimilars
With decades of experience in testing of biologics or biosimilar products, we offer the preclinical, clinical, and bioanalytical expertise you need to move your large molecule programs forward. In fact, more than 40% of our current preclinical and clinical studies are conducted on biologics.
From conducting the world’s first safety and tolerability testing of a novel combustible cannabis formulation, to testing synthetic cannabinoids or products for the recreational market, Altasciences is a world leader in cannabis preclinical and clinical testing.
Safety and abuse potential testing of cannabis and new tobacco products (such as electronic nicotine delivery or heat-not-burn systems) is becoming more complex. You can rely on Altasciences’ experience — a CRO that understands clinical design and requirements for conducting smoking/vaping studies.
Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.
ROUTES OF ADMINISTRATION
We have expertise with multiple routes of administration, including the ones listed below. If your study needs a route not listed here, please contact us.
- Oral (gavage, diet, capsule)
- Parenteral (intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal and intra-articular)
CREATE A TIMELINE FOR YOUR CLINICAL STUDY
Our interactive timeline application helps you plan your early stage clinical program deliverables far in advance.
PARTICIPANT RELATIONSHIP MANAGEMENT
We offer proven ability to meet recruitment milestones of healthy participants and patients, and upscale facilities designed for optimum recruitment and retention. Our processes and extensive database effectively match study requirements, including inclusion and exclusion criteria, length of confinement, and number of return visits, to participant profiles. This facilitates rapid recruitment — ensuring on-time start-up and participant retention for both short- and long-term confinements. Our full-time, in-house recruiting staff follows a proactive and study-specific recruitment strategy that makes use of multiple media channels.
Our searchable database of screening histories allows us to give you feedback on the percentage of our population that will qualify. When it comes time to recruit patients, it allows us to target those that are more likely to qualify. Additionally, our network of specialized clinicians and relationships with local hospitals provide access to a wide range of additional patient populations.
Committed to Safety
Full-time, dedicated research physicians oversee all aspects of our clinical trials. All participants are assessed daily by an Investigator and under constant close supervision. When needed, we can use our telemetry system to monitor ECGs and pulse oximetry. Panic buttons are strategically placed throughout our clinics so that participants can alert clinical staff of emergencies. Advanced Cardiac Life Support (ACLS) provider coverage is on-site 24/7, with all clinical staff certified in Basic Cardiac Life Support and trained in scenario-based response. Our clinical facilities are under 24/7 video surveillance, have controlled access throughout, and are in close proximity to major hospitals.
COMPREHENSIVE FULL-SERVICE OFFERING
Our full support service model complements our clinical offering to best meet your needs.
- Scientific, Regulatory and Strategic Guidance
- Protocol Development
- Project Management
- Analytical Chemistry
- Bioanalysis (small and large molecules)
- Data Management