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.
PARTICIPANTS IN OUR
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.
- Comprehensive Full-Service CROComprehensive Full-Service CROOur full support service model complements our clinical trial services to best meet your needs. Scientific, Regulatory and Strategic Guidance, Protocol Development, Project Management, Bioanalysis (small and large molecules), Data Management, Biostatistics
Clinical Monitoring, Reporting, CDISC, Archiving.
- First-in-Human Trials (FIH)First-in-Human Trials (FIH)A great place to start your early clinical development is with a first-in-human (FIH) study conducted by Altasciences. Our experience includes more than 360 FIH studies for both small molecules and biologics.
- Proof of Concept (POC)Proof of Concept (POC)Reach critical milestones faster with our integrated, comprehensive proof of concept study services. Adept at the design and conduct of phase I clinical trials, we will deliver your clinical research efficiently and effectively. Supported by regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, your POC clinical trial is in excellent hands with Altasciences.
- Pharmacokinetics in Special PopulationsPharmacokinetics in Special PopulationsWe can rapidly recruit a broad range of special population participants for PK studies, using a combination of our existing database and participant outreach.
- Drug-Drug InteractionDrug-Drug InteractionDrug-drug and drug-alcohol interaction studies are important steps in finalizing the clinical pharmacology details of your product label. Trust your DDI and drug-alcohol studies to a CRO that has been offering clinical trial services, designing and conducting such studies for decades.
- PK/PDPK/PDComprehensive, top-quality PK/PD studies support and accelerate your drug development process. We offer comprehensive PK/PD analysis for preclinical and clinical studies, in a wide range of routes of administration and matrices.
- Bioavailability/BioequivalenceBioavailability/BioequivalenceAltasciences has designed, conducted, analyzed, and reported on more than 1,600 bioavailability (BA) and bioequivalence (BE) studies for more than 1,200 products or combinations during our 25+ years of offering clinical trial services.
- Renal and Hepatic ImpairedRenal and Hepatic ImpairedRenal and hepatic impaired studies are often part of the last set of clinical pharmacology studies needed for regulatory approval. Plan ahead with Altasciences to keep you moving seamlessly toward approval.
- Biologics/BiosimilarsBiologics/BiosimilarsWith decades of experience in testing of biologics or biosimilar products, we offer the comprehensive 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.
- Cannabis/CBD drugsCannabis/CBD drugsFrom conducting the world’s first safety and tolerability testing of a novel combustible cannabis formulation, to testing synthetic cannabinoids or products for the recreational market, Altasciences' clinical trial services are world leaders in cannabis testing.
- Topical/TransdermalTopical/TransdermalBenefit 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.
- OphthalmologyOphthalmologyOphthalmology safety or efficacy assessments can be performed on site or by leveraging our partnerships with local specialty clinics in healthy participants or patients. Our Montréal facility has an ophthalmologist Principal Investigator who performs assessments both at his office and our clinic, located in the same building.
- Driving SimulationDriving SimulationWith more than 13,000 simulated drives, we have extensive experience designing and conducting driving simulation studies to establish the extent and duration of drug-related impairment, or to demonstrate an improvement in driving ability after pharmaceutical treatment.
- Human Abuse PotentialHuman Abuse PotentialStudies looking at human abuse potential and abuse-deterrent formulations require clinical trial services that include specialized pharmacies, highly trained staff, robust patient databases, and the operational skill to retain participants.
- QT AssessmentQT AssessmentWe 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.
- CLINICAL SITE SOLUTIONSCLINICAL SITE SOLUTIONSLeveraging extensive data, our global network of 100+ clinical sites and unrivalled industry knowledge, we are uniquely positioned to support enrollment in healthy normal volunteer and specialty population trials.
specialty assessments capabilities
Within the context of our early phase clinical research services, we have specialized expertise in:
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
- CSF collection
- Pain Models
- Driving Simulation
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.
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.
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.
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.
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.
- Clinical monitoring
- Clinical Trial Site Solutions
- Data management
- Full-time equivalent (FTE) capabilities
- PK/PD analysis and interpretation
- Program management
- Project management
- Regulatory support
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 10 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.
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.
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 25 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.