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.
- 400 beds
- 250+ clinical trials completed annually
- 345K+ participants in our combined database MORE INFO
TYPES OF CLINICAL STUDIES
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First In Human (FIH)
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Proof of Concept
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Driving Simulation
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Human Abuse Potential
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BIOAVAILABILITY/BIOEQUIVALENCE
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DRUG-DRUG INTERACTION
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Pharmacokinetics in Special Populations
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QT ASSESSMENT
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RENAL AND HEPATIC IMPAIRED
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Imaging
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Biologics / Biosimilars
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.
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CANNABIS
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SMOKING/VAPING
SMOKING/VAPING
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.
THERAPEUTIC AREAS
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)
- Sublingual
- Parenteral (intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal and intra-articular)
- Infusion
- Ocular
- Inhalation
- Intranasal
- Topical
- Intravaginal
- Rectal
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
- Bioanalysis (small and large molecules)
- Data Management
- Biostatistics
- Reporting
- CDISC
- Archiving
Consult our Support Services Overview