Clinical Research Services For Early Phase Drug Development

Accelerate early‑phase development with focused clinical research—Phase I, Phase IIa, and clinical pharmacology/NDA‑enabling trials. We support small and large molecules across routes of administration and recruit both healthy volunteers and special and patient populations.

Consult our Clinical Services Fact Sheet for details on our early-phase clinical research capabilities.

What Sets Altasciences Apart in Early-Phase Clinical Development?

Progress in early-phase trials hinges on precision, speed, and flexibility. With our focus on early clinical development, we are uniquely positioned to help you progress through critical milestones quickly and reliably. If you are looking for full support and planning of your program to maximize smooth progression, or you have a single study that requires immediate design and execution, Altasciences is the ideal CRO partner.

580+ Beds

285+ Clinical Trials Completed Annually

400k+ Participants In Our Combined Database

Integrated Solutions for Clinical Research Services

We offer a turnkey clinical development solution designed to meet all your needs, whether you require full-service support or something in between. As early-phase clinical research experts, you can expect comprehensive solutions for first-in-human (FIH) trials, clinical pharmacology/ NDA-enabling studies, and proof-of-concept (PoC) studies. Our team handles every aspect of your clinical development, ensuring seamless conduct from start to finish. With our deep expertise, timeline flexibility, and excellent enrollment results, we tailor our services to suit your specific project requirements.

Trust us to provide the guidance, support, and expertise needed to safely accelerate your drug development journey, efficiently.

FIH Trials

We specialize in providing comprehensive FIH clinical research services, guiding you from preclinical development through early-phase trials. Our clinical research experts have extensive experience in designing, conducting, and reporting on FIH studies, ensuring safety, regulatory compliance, and rapid progression to the next phase. With state-of-the-art facilities and expert clinical pharmacologists, we offer tailored solutions that meet the unique needs of each investigational product.

PoC Trials

With a team of highly skilled regulatory experts, bioanalytical scientists, statisticians, medical professionals, and clinical operations specialists, we excel in designing and conducting PoC studies. Our integrated and comprehensive approach allows you to safely reach critical milestones faster and with confidence.

Clinical Pharmacology Trials

We offer expert clinical pharmacology trial services designed to optimize the development of new therapies. Our team specializes in:

• Pharmacokinetic (PK) and pharmacodynamic (PD) studies
• Bioavailability/bioequivalence (BA/BE) trials
• Drug-drug interaction (DDI) assessments
• Food/age/gender effects on PK/PD
• Renal and hepatic impairment
• Driving simulation
• Human abuse potential
• Ethnobridging
• QT assessment

Specialized Clinical Capabilities

Within the context of our early phase clinical research services, we have specialized expertise in:

• CNS-Active Drugs
• Cardiac Safety Assessments
• Ethnobridging Trials
• Imaging and Scans
• PBMC Collection and Separation
• Topical/Transdermal Assessments
• Opthalmological Evaluations
• Inhalation Techniques

Efficient Study Start-Up and Clinical Research Services Timelines

We pride ourselves on our ability to mobilize quickly. For instance, we recently reduced the start-up time from the industry standard of 12 weeks to less than four weeks. Our approach includes effective communication, strategic planning, and a dual project management structure, ensuring seamless alignment between our internal teams and the sponsor. This facilitates prompt decision-making and rapid issue resolution.

By streamlining processes—such as contract execution, regulatory document preparation, and subject recruitment—Altasciences demonstrates a commitment to efficiency and timely results. Our strong project management, combined with a dedicated internal team and collaborative relationships with sponsors, leads to significant reductions in start-up timelines.

With three clinical pharmacology units and co-located bioanalytical laboratories in the U.S. and Canada, we provide multiple regulatory pathways—Investigational New Drug (IND) and Clinical Trial Application (CTA) in Canada and the EU. Our focus on efficiency ensures rapid start-up and streamlined timelines for your projects.

Optimized Recruitment Strategy and Rapid Enrollment

With a pool of over 400,000 healthy normal participants, special populations and patients, we rapidly recruit and enroll full panels. Our recruitment strategies and database ensure we meet enrollment targets swiftly, so your study progresses without delays.

Comprehensive Clinical Research Services

We offer a wide range of services for conducting early-phase clinical trials and will manage every aspect of your trial from start to finish. Our comprehensive services include:

Program/Project Management

Our program/project management solution is tailored to navigate the complexities of clinical research services. We excel in managing diverse study designs across a wide range of therapeutic areas, delivering customized solutions to meet your specific early-phase drug development needs.

With decades of expertise in the entire early-phase drug development spectrum—including preclinical studies, clinical trials, manufacturing and analytical services, bioanalysis, and complementary CRO services—our team also ensures comprehensive management for large-scale, end-to-end programs.

Protocol Review and Development

Our approach focuses on efficient timelines and precise data collection. Whether starting from scratch or refining an existing protocol, we ensure a streamlined process to support informed decision-making and meet critical study milestones with regulatory-compliant, customized protocols.

Early-Phase Clinical Conduct

Our three state-of-the-art clinics across North America are fully equipped to conduct early-phase trials. Our expert teams manage all aspects of your trials with adherence to the highest quality and safety standards.

Clinical Research Associate (CRA) and Clinical Monitoring

We provide timely tracking of pharmacokinetics (PK) and pharmacodynamics (PD) data, safety assessments, and adverse event reporting. This ensures regulatory compliance and maintains data integrity throughout the trial.

Bioanalytical Services

Our co-located, state-of-the-art bioanalytical labs will develop and validate methods specific to your clinical trial. We also have over 685 validated methods for a wide range of compounds. By leveraging these established assays, we deliver precise and timely PK data to meet regulatory standards. This enables faster decision-making and comprehensive label information.

Data Services and Reporting

We manage data collection and analysis, and provide comprehensive reporting to deliver reliable, well-organized, and actionable, early-phase clinical trial results—on time.

Regulatory Consulting

Our experts provide guidance on when and how to conduct your early-phase clinical trial, helping you map out a clear, efficient path through the complex regulatory process.

Purpose-Built Phase I Clinical Research Units

Our Phase I clinical trial units in the U.S. and Canada offer you over 580 beds, and:

• Dedicated participant screening facilities
• Long-term stay facilities
• Outpatient and return units
• Suite of 12 on-site driving simulators, with space for 20 more
• Customized facilities for in-patient psychedelic settings
• Secure pharmacies with video monitoring and retinal scanning
• Pharmacists experienced with complex and narcotic compounding
• Access to co-located ophthalmology clinic
• Co-located bioanalytical laboratories

Commitment to Safety

Our clinical facilities are under 24/7 video surveillance, have controlled access throughout, and are near major hospitals. Full-time research physicians oversee all aspects of our early clinical development studies. Trial participants are assessed daily by an Investigator and are under constant supervision. When needed, we have a telemetry system to monitor ECGs and pulse oximetry. There are also strategically placed panic buttons throughout our clinics, and Advanced Cardiac Life Support (ACLS) provider coverage on-site 24/7. In addition, all clinical staff are certified in Basic Cardiac Life Support and trained in scenario-based response.

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 comprehensive support research services and bioanalytical expertise.