Clinical Research Services for Early Phase Drug Development
Not all CROs are created equal. Your project deserves the most efficient, high quality clinical research services, to advance through the early phases of drug development quickly and seamlessly.
Advancing your drug candidate smoothly to proof of concept is what we do best. Work with clinical research services experts who leverage your preclinical data in the design and conduct of critical early phase research, and generate high-quality data to inform the best decisions for your program. Whatever the size of your biopharmaceutical company, you can benefit from our decades of expertise in the clinical pharmacology studies required for regulatory submissions, in a wide range of therapeutic areas, for small molecules and biologics, within NDA or 505(b)(2)/Hybrid applications.
Our Early Phase Clinical Development Solutions
Partner with us for your early phase clinical studies. We customize our process to suit your requirements—working with you to design the most robust clinical program, and conducting the testing that advances you through the phases with ease. Our advanced level of clinical expertise enables us to successfully recruit and conduct clinical trials involving a broad range of healthy normal, special, and patient populations.
Leveraging a combination of our existing database and proactive participant outreach strategies, we can help you get ahead in a wide range of study types, methods of administration, and therapeutic areas.
Consult our Clinical Services Fact Sheet for more information on our clinical trial service capabilities.
BEDS
CLINICAL TRIALS
COMPLETED
ANNUALLY
PARTICIPANTS IN OUR
COMBINED DATABASE
Clinical Research Services And Solutions
Our clinical research services are available for multiple routes of administration: oral (buccal, sublingual); topical; transdermal; parenteral (intravenous, subcutaneous, intramuscular, intraarticular, intradermal); ocular; intranasal; intravaginal; rectal. And more—contact us if you need a route not listed here.
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Comprehensive Full-Service CRO -
First-in-Human Trials (FIH) -
Proof of Concept (POC) -
Pharmacokinetics in Special Populations -
Drug-Drug Interaction -
PK/PD -
Bioavailability/Bioequivalence -
Renal and Hepatic Impaired -
Biologics/Biosimilars -
Cannabis/CBD drugs -
Topical/Transdermal -
Ophthalmology -
Driving Simulation -
Human Abuse Potential -
QT Assessment -
CLINICAL SITE SOLUTIONS
specialty assessments capabilities
Within the context of our early phase clinical research services, we have specialized expertise in:
CNS-Active Drugs
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 preclinical and bioanalytical expertise.
- Human Abuse Potential
- Physical Dependency
- Factor 8 Analysis
- Cognition
- CSF collection
- Pain Models
- Driving Simulation
- Psychedelics
Cardiac Safety Assessments
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.
Ethnobridging Trials
Reach regulatory milestones faster with ethnobridging clinical trials. Altasciences can help reduce your drug development timelines by researching Asian populations where studies have already begun in North America or Europe, according to protocols accepted by Asian countries.
Imaging and Scans
Altasciences has the experience and affiliated facilities to incorporate imaging into most clinical pharmacology studies.
PBMC Collection and Separation
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 Assessments
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 Evaluations
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.
CLINICAL RESEARCH SUPPORT SERVICES
Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone in your drug development program. Altasciences is here to help you get there, design, conduct, and report on your study, by providing you with a full range of complementary CRO support services, either as part of a complete program or as a stand-alone offering.
- Biostatistics
- Clinical monitoring
- Clinical Trial Site Solutions
- Data management
- Full-time equivalent (FTE) capabilities
- PK/PD analysis and interpretation
- Program management
- Project management
- Regulatory support
Consult our Integrated Research Support Services fact sheet.
Purpose-Built Clinical Phase I Units
With Phase I clinical trial units in the U.S. and Canada, we offer you:
- Secure pharmacies with video monitoring and retinal scanning
- Pharmacists experienced with complex and narcotic compounding
- 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
- Access to co-located ophthalmology clinic
With Altasciences, you can expect full panels for your trials, whether with healthy normal volunteers or patient populations. Our clinical trial recruitment processes effectively match study requirements to our extensive database of participant profiles, to facilitate rapid recruitment — ensuring on-time start-up and participant retention for both short- and long-term stays. We have a proactive and study-specific recruitment strategy that makes use of multiple media channels, to support the efforts of our full-time, in-house recruiting staff.
We can easily search our database of screening histories to give you feedback on the percentage of our population that will qualify. When it comes time to recruit patients, we target those with a high chance of qualifying. Additionally, our network of specialized clinicians and relationships with local hospitals, provide access to a wide range of additional patient populations.
Full-time research physicians oversee all aspects of our early clinical development services. Study participants are assessed daily by an Investigator, and are under constant supervision. We have a telemetry system to monitor ECGs and pulse oximetry, as required. There are strategically placed panic buttons throughout our clinics for participants to alert clinical staff in case of an emergency. Advanced Cardiac Life Support (ACLS) provider coverage is on-site 24/7, and all clinical staff are 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 near major hospitals.
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.
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.
Early Phase Clinical Research Services–FAQs
What clinical trial services are available?
Altasciences offers fully integrated regulatory, scientific and strategic guidance, protocol development, clinical pharmacology and monitoring, state-of-the-art bioanalysis, expert project and data management that is CDISC compliant. We also have highly skilled teams in biostatistics and medical writing/reporting. For your small molecules, we offer manufacturing and analytical services. Whether you are looking for a single study or full program, our clinical trial services are here to support you.
How to make the most of your CRO partnership?
When choosing a CRO partner for clinical trial services, expert, comprehensive, integrated, agile, and flexible, are all qualities to look for. Altasciences is a mid-size, forward-thinking CRO with all the scientific expertise and experience to successfully manage your drug development program, with a fully integrated preclinical to clinical offering, including expert bioanalysis, small molecule manufacturing and analytical services, and more.
How do you ensure that your clinical trial services provider has a quality culture?
Ensuring that a CRO treats the quality of their work with the utmost care is crucial. At Altasciences, quality is our primary driver, for clinical trial services, and every other service offering we have, from development to bioanalysis to manufacturing. Ensuring that we are always aligned with the guidelines, and that our interactions with regulatory agencies are successful, are critically important. Read more about our approach to successful regulatory audits here.
How does Altasciences ensure an integrated approach for their comprehensive services?
Our vision is to provide sponsors with a seamless drug development process, from lead candidate selection through to proof of concept. We provide the scientific, strategic, and regulatory expertise to guide you through each phase of development, from preclinical to clinical trial services, and beyond. With one CRO, integrated, comprehensive, and scientifically advanced, you only need to Tell Us Once™ about your program goals, and we’ll take care of the rest.
How much industry experience does Altasciences have?
Our company has been thriving for over 30 years, consistently delivering top-quality clinical trial services to sponsors worldwide, in addition to comprehensive preclinical services, manufacturing, and analytical services. Our teams offer vast and broad industry experience from CROs, biopharma and pharma, academia, government, and other industry sectors.