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.
Keep scrolling to explore how we can support your clinical development goals.
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.
Clinical Pharmacology Units
Phase I and II trials conducted annually
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:
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
CNS-active drug development requires specialized assessments focused on (among others) cognitive function, dependence evaluation, and abuse potential. Our CNS Center of Excellence has the expertise to advance your clinical program with the most rigorous attention to quality and safety. We offer regulatory guidance, specially adapted clinical spaces for psychedelic trials, and highly trained personnel who ensure the safety and comfort of all participants. We have fully integrated services that will take your program to the next level, including nonclinical and bioanalytical expertise.
- Human Abuse Potential
- Physical Dependence
- Eight-Factor Analysis
- Cognition
- CSF collection
- Pain Models
- Driving Simulation
- Psychedelics
Cardiac Safety Evaluations
We have been designing and conducting QT studies since the FDA E14 guidance was finalized. Our clinical trial services team has experience in both early cardiac safety assessment and thorough QT prolongation studies.
Imaging and Scans
Altasciences has the experience and affiliated facilities to incorporate imaging into most clinical pharmacology studies.
PBMC Collection and Isolation
Evaluate immune responses and gain a deeper understanding of immune system function pre-dose, post-dose, and at other integral stages of testing with Altasciences’ expertise in routine isolation of peripheral blood mononuclear cells (PBMCs). Through effective harvesting, processing, and analysis of PBMCs, researchers can characterize the human immune response to disease and various immune-targeted therapeutic agents.
Topical/Transdermal Studies
Benefit from our decades of experience with NDA, 505(b)(2) and marketed TDS products, including narcotics, antipsychotics/CNS therapeutics, hormonal replacement therapies, nicotine, analgesics, immunologicals, and more. We are fully versed on FIH, NDA and ANDA study requirements for North America and Europe, and can advance your topical research efficiently and effectively.
Opthalmological Studies
Ophthalmology safety or efficacy assessments can be performed on site or by leveraging our partnerships with local specialty clinics in healthy participants or patients. Our Montreal facility has an ophthalmologist Principal Investigator who performs assessments both at his office and our clinic, located in the same building.
Inhalation Studies
The lungs are an excellent target for drug delivery, both as the end organ for the treatment of respiratory diseases and as the route of administration for systemic therapies. The lungs provide direct access for treatment of respiratory diseases, while providing an enormous surface area and a relatively low enzymatic, controlled environment for systemic absorption of medications.
We offer expertise in multiple modes of inhaled drug delivery, including nebulizers, metered-dose and dry-powder inhalers, nasal sprays, and other devices. We have conducted trials on these drugs from FIH to ANDA. Our clinical research services utilize purpose-built inhalation/specialty negative pressure rooms for the dosing process to ensure a safe and contained environment for participants and staff.
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
Speed and Study Start-Up
Study start-up sets the foundation for early-phase clinical development timelines. When executed efficiently, it enables earlier first subject, first dose and facilitates steady progress across milestones.
We optimize study start-up by coordinating critical activities in parallel rather than in sequence. Regulatory preparation, protocol development, site readiness, and recruitment planning move forward together, supported by aligned teams and focused program management.
Consistent communication between sponsors and functional teams supports rapid decision-making during study start-up. We identify and resolve potential obstacles early so that your study stays on schedule.
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.
Related Resources
Consult our Clinical Services Fact Sheet for more information on our clinical trial service capabilities.
Consult our Pharmacy on Demand Fact Sheet to see how we save you time with integrated processes and synergies between manufacturing and clinic.
Consult our Clinical Sample Kits Fact Sheet to learn more about our streamlined sample management process, and comprehensive kits.
Frequently Asked Questions About Clinical Research Services
How long does it take to start a first-in-human clinical trial?
Study start-up timelines depend on protocol complexity, regulatory readiness, and site preparation.
Altasciences accelerates start-up time by aligning regulatory planning, protocol development, site readiness, and recruitment activities from the outset. By executing these steps in parallel and maintaining direct communication between teams, studies can move from award to first subject first dose significantly faster than typical industry timelines.
What causes delays in early-phase clinical trials?
Delays often result from protocol amendments, regulatory feedback, recruitment challenges, or gaps between nonclinical data and clinical design. These issues frequently emerge during study start-up or early execution.
Early alignment across scientific, regulatory, and operational teams helps prevent these delays. When study design reflects upstream data and downstream objectives, programs progress with fewer interruptions and less rework.
How does integration impact clinical trial timelines?
Having integrated nonclinical and clinical services reduces delays between phases by connecting teams, data, and decision-making across the development process. Instead of waiting for one phase to complete before starting the next, integrated programs allow activities to move forward in parallel.
This approach supports faster study start-up, more efficient execution, and earlier access to decision-making data.
How do you handle recruitment for specialized or hard-to-find populations?
Recruitment for specialized populations requires targeted strategies, well-characterized participant databases, and dedicated screening processes.
Altasciences has the advanced level of clinical expertise required to successfully recruit and conduct clinical trials involving special and patient populations. We support these studies with an active database of 400,000+ participants and access to a network of 500+ partner sites, as well as local research teams and hospitals. Our clinical pharmacology units can quickly identify viable study participants based on protocol inclusion/exclusion criteria. Our dedicated recruitment team is highly trained to carefully pre-screen participants before scheduling them for an office screening appointment, where they meet with one of our full-time healthcare professionals; thus, reducing study start-up timelines.
Do we need to plan beyond our current development phase?
Yes. Decisions made during early-phase clinical development impact later stages of the program. Planning only for the immediate study often leads to delays, protocol changes, or additional work later.
Aligning clinical strategy with future milestones helps reduce rework, supports more efficient progression, and improves the overall development timeline.
What level of support should we expect from a clinical research partner?
Clinical research services can range from executing a single study to managing an entire early-phase program. The level of support should match the complexity of the program and the sponsor’s internal capabilities.
Altasciences provides full-service support across clinical development, including study design, regulatory strategy, medical writing, data management services, and study conduct. This allows sponsors to work with one partner rather than managing multiple vendors.
What factors should I consider when evaluating clinical research services?
To avoid delays later in development, sponsors consider things like:
- How quickly can we move from IND to first-in-human?
- What factors will impact study start-up and execution timelines?
- How can we streamline the transition between nonclinical and clinical phases?
- What level of integration will improve efficiency?
- How will recruitment and site readiness affect our timelines?
Evaluating these questions early supports more accurate planning, fewer adjustments during execution, and faster progression to proof-of-concept.
Altasciences supports this process by aligning clinical strategy, operational planning, and data requirements from the outset, helping sponsors make informed decisions that keep programs moving forward.
Can you support studies beyond your own clinical sites?
Yes. In addition to our purpose-built clinical pharmacology units, Altasciences can support studies through a network of qualified partner sites when broader geographic reach or specific patient populations are required.
Site selection, study start-up, and project/program management are coordinated through Altasciences to maintain consistent study execution, data quality, and timeline alignment. This allows sponsors to expand beyond a single location without taking on the complexity of managing multiple vendors.