Clinical Research Services For Drug Development

Accelerate early-phase drug development with Altasciences' integrated Phase I, Phase IIa, clinical pharmacology, and NDA-enabling clinical research services. Whether you’re advancing a small molecule, biologic, or another advanced therapeutic, we can support your program across multiple routes of administration, enrolling healthy volunteers, patient populations, and specialized cohorts to meet diverse study requirements.

From first-in-human (FIH) and proof-of-concept studies to clinical pharmacology, bioavailability/bioequivalence (BA/BE), and NDA-enabling trials, our experienced teams integrate clinical operations, participant recruitment, bioanalysis, medical oversight, regulatory support, and project management within a single organization. This seamless approach reduces technology transfer, accelerates study start-up and enrollment, and delivers high-quality, regulatory-ready data that helps you make confident development decisions and advance programs more efficiently.

Keeping Your Clinical Program Moving

Early-phase clinical research timelines are often influenced by factors that emerge during study start-up and early execution. These are factors like protocol revisions following regulatory feedback, misalignment between nonclinical findings and clinical design, recruitment for specialized populations, and/or data incompleteness and interpretability, requiring additional studies.

Sounds familiar? We help you overcome these challenges through early cross-functional alignment, coordinated planning, and continuous data visibility across the program. By aligning your clinical strategy with both upstream data and downstream objectives, we reduce rework and help your study progress efficiently with enable with predictable timelines and faster decision-making.

Proven Clinical Expertise

Altasciences delivers clinical research services at scale while maintaining consistency across study design, conduct, and data quality.

• 3 Clinical Pharmacology Units
• 285+ Phase I and II trials conducted annually
• 400,000+ Participant Database

Programs supported by Altasciences have reached proof-of-concept from first safety assessment in approximately two years, compared to typical industry timelines of 2.5 to 5 years.

These results reflect a coordinated approach across our clinical, bioanalytical, and operational teams, allowing studies to progress efficiently with consistent results.

Clinical Research Capabilities

We can support your program across the full range of early-phase studies, from first-in-human through proof-of-concept. Whether it’s for a standalone study or a complex, multi-disciplinary programs, we have your back.

Core Study Types

Our core studies generate the safety, tolerability, pharmacokinetic, and early efficacy data required to inform your development decisions.

First-in-Human (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.

Proof-of-Concept (POC) Studies

With a team of highly skilled regulatory experts, bioanalytical scientists, statisticians, medical professionals, and clinical operations specialists, we excel in designing and conducting proof-of-concept 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

Altasciences supports a wide range of specialized study designs and therapeutic requirements. We design each study to meet specific regulatory, scientific, and program objectives.

• CNS Clinical Trials
• Cardiac Safety Evaluations
• Topical/Transdermal Studies
• Opthalmological Studies
• Inhalation Studies
• Imaging and Scans
• PBMC Collection and Isolation

End-to-End Clinical Research Support

Beyond simply executing on your study, we can manage every aspect of your trial from start to finish.

• Protocol development and review
• Regulatory strategy and submission support
• Medical writing
• Clinical monitoring
• Clinical trial site identification and management
• Data management and biostatistics
• Project and program management
• Reporting and archiving
• Bioanalytical method development and sample analysis
• Drug formulation and manufacturing

Patient Recruitment and Enrollment

Patient recruitment plays a key role in maintaining study timelines and supporting overall program efficiency.

Recruitment efforts are supported by a large, well-characterized participant database and dedicated screening and enrollment teams. With access to over 400,000 participants―including healthy volunteers, patients, and specialized populations―your studies can begin recruitment quickly and reach full enrollment more reliably.

90% retention rate in both short-term and long-term study stays.

We tailor recruitment strategies to your protocol, with experienced teams managing screening, scheduling, and follow-up based on the specific requirements of your early-phase studies.

We also support specialized recruitment needs, including ethnobridging studies and targeted populations, with access to diverse participant pools across North America.

For studies extending beyond our dedicated clinical units, we work with a network of over 500 qualified partner sites. This means that you can access even broader patient populations and geographic regions when required, while maintaining centralized oversight and consistent study execution. Site selection, start-up, and management are coordinated centrally through Altasciences to ensure alignment, quality, and adherence to your overall program timelines.

Integrated Clinical Development Approach

When drug development phases operate in silos, progress can slow. But when there’s alignment across teams, data, and decisions, programs move forward more efficiently.

Altasciences approaches clinical research as part of a continuous development process. Clinical strategy is developed alongside nonclinical data, bioanalytical insights, and manufacturing readiness, rather than handed off between phases. Study design, regulatory preparation, and operational planning move forward together.

Dedicated program management coordinates activities across all functions. Teams work from a shared timeline with clear ownership of deliverables and visibility into critical milestones. Communication flows directly between sponsors and functional leads, enabling faster decisions without unnecessary bottlenecks.

In turn, we can anticipate challenges earlier, refine study design with full context, and avoid delays that may emerge during execution. Your program will also benefit from continuity across the development lifecycle, keeping teams aligned, data connected, and programs progressing without the stop-and-start disruptions that define traditional CRO models.

Throughout study execution, your data remains connected across disciplines. Bioanalytical results, clinical observations, and operational updates support ongoing decision-making, allowing teams to adjust quickly and keep studies on track.

Purpose-Built Phase I Clinical Research Units

Altasciences operates three dedicated Phase I clinical research units in the United States and Canada, with over 580 beds designed to support a wide range of early-phase study requirements.

Key capabilities include:

• Dedicated participant screening facilities
• Long-term stay units for extended study designs
• Outpatient and return-visit units
• 12 on-site driving simulators (expandable to 20)
• Customized facilities for in-patient psychedelic studies
• Secure pharmacies with video monitoring and retinal scanning
• Pharmacists experienced in complex and narcotic compounding
• Access to a co-located ophthalmology clinic
• Co-located bioanalytical laboratories

Commitment to Study Participant Safety

Our clinical facilities feature 24/7 surveillance, controlled access, and proximity to major hospitals. Studies are overseen by full-time research physicians, with daily participant assessments and continuous supervision. Advanced safety measures, including telemetry monitoring when needed and 24/7 on-site ACLS coverage, support rapid response, while all clinical staff are trained in emergency and scenario-based care.