Our Solutions

COMPREHENSIVE CLINICAL TRIAL SERVICES

For your early phase clinical studies, our experts in clinical trial services ensure the design and conduct of studies generate the data that meets your objectives, leveraging preclinical data in moving your programs to proof of concept. We have expertise in clinical pharmacology studies for regulatory submissions, in many of therapeutic areas, for small molecules, biologics, and 505(b)(2) or Hybrid applications, on behalf of biopharmaceutical companies of every size.

For your early phase clinical studies, our experts in clinical trial services customize our process to suit your needs—working with you to leverage preclinical data in the design and conducting the testing that takes your programs through to proof of concept. We offer comprehensive clinical services for wide range of study types on behalf of biopharmas of every size.

Consult our Clinical Services Fact Sheet

  • 400 beds
  • 250+ clinical trials completed annually
  • 345K+ participants in our combined database MORE INFO

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TYPES OF CLINICAL STUDIES

  • FIH Studies - First In Human Trials - First In Man Clinical Trials

    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 recent clinical trial services experience includes more than 200 FIH studies for both small molecules and biologics.

  • Proof of Concept Clinical Trials - POC Studies

    Proof of Concept

    Proof of Concept

    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 POC clinical research efficiently and effectively. Supported by regulatory experts, bioanalytical scientists, experienced biostatisticians and medical writing teams, your proof of concept clinical trial is in excellent hands with Altasciences.

  • Driving Simulation Trials - Driving Simulator Research

    Driving Simulation

    Driving Simulation

    With more than 10,000 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 Potential (HAP) - Human Abuse Liability (HAL)

    Human Abuse Potential

    Human Abuse Potential

    Studies 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.

  • Bioavailability Studies - Bioequivalence Solutions & Clinical Trials

    BIOAVAILABILITY​/​BIOEQUIVALENCE

    BIOAVAILABILITY​/​BIOEQUIVALENCE

    Altasciences 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.

  • Drug-Drug Interaction (DDI) Studies

    DRUG-DRUG INTERACTION

    DRUG-DRUG INTERACTION

    Drug-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.

  • Altasciences-clinical-services-Pharmacokinetics-in-Special-Populations

    Pharmacokinetics in Special Populations

    Pharmacokinetics in Special Populations

    We can rapidly recruit a broad range of special population participants for PK studies, using a combination of our existing database and participant outreach.

  • QT Assessment - QT Services - QT Studies

    QT ASSESSMENT

    QT ASSESSMENT

    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.

  • Renal and Hepatic Impaired Clinical Studies

    RENAL AND HEPATIC IMPAIRED

    RENAL AND HEPATIC IMPAIRED

    Renal 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.

  • Imaging Modalities - Imaging Clinical Services

    Imaging

    Imaging

    Altasciences has the experience and affiliated facilities to incorporate imaging into most clinical pharmacology studies.

  • Biosimilar Drug Development - Biologics Bioanalysis

    Biologics / Biosimilars

    Biologics / Biosimilars

    With 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 Clinical Trials & Research - Cannabis Clinical Studies

    CANNABIS

    CANNABIS

    From 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.

  • Smoking Clinical Trials - Smoking CRO - Vaping Studies

    SMOKING/VAPING

    SMOKING/VAPING

    Safety and abuse potential testing of cannabis and new tobacco products (such as electronic nicotine delivery or heat-not-burn systems) is becoming more complex. You can rely on Altasciences’ experience — a CRO with comprehensive clinical trial services, that understands clinical design and requirements for conducting smoking/vaping studies.

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.

Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.

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ROUTES OF ADMINISTRATION

We have expertise with multiple routes of administration, including the ones listed below. If your study needs a route not listed here, please contact us.

  • Oral (gavage, diet, capsule)
  • Sublingual
  • Parenteral (intravenous, subcutaneous, intramuscular, intraperitoneal, intrathecal and intra-articular)
  • Infusion
  • Ocular
  • Inhalation
  • Intranasal
  • Topical
  • Intravaginal
  • Rectal

PARTICIPANT RELATIONSHIP MANAGEMENT

We offer proven ability to meet recruitment milestones of healthy participants and patients, and upscale facilities designed for optimum recruitment and retention. Our clinical trial service processes and extensive database effectively match study requirements, including inclusion and exclusion criteria, length of confinement, and number of return visits, to participant profiles. This facilitates rapid recruitment — ensuring on-time start-up and participant retention for both short- and long-term confinements. Our full-time, in-house recruiting staff follows a proactive and study-specific recruitment strategy that makes use of multiple media channels.

Our searchable database of screening histories allows us to give you feedback on the percentage of our population that will qualify. When it comes time to recruit patients, it allows us to target those that are more likely to qualify. Additionally, our network of specialized clinicians and relationships with local hospitals provide access to a wide range of additional patient populations.

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COMMITTED TO SAFETY

Full-time, dedicated research physicians oversee all aspects of our clinical trials services. All participants are assessed daily by an Investigator and under constant close supervision. When needed, we can use our telemetry system to monitor ECGs and pulse oximetry. Panic buttons are strategically placed throughout our clinics so that participants can alert clinical staff of emergencies. Advanced Cardiac Life Support (ACLS) provider coverage is on-site 24/7, with all clinical staff 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 in close proximity to major hospitals.

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COMPREHENSIVE FULL-SERVICE CRO OFFERING

Our 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

Consult our Support Services Overview

See Research Support Services to learn more

Clinical Services - FAQs

What clinical trial services are available?

Altasciences offers fully integrated regulatory, scientific and strategic guidance, protocol development, clinical pharmacology and monitoring at two locations in the U.S.A. and Canada, state of the art bioanalysis at our lab in Canada, expert project and data management (CDISC compliant). We also have highly skilled teams in biostatistics and medical writing/reporting. For your small molecules, we have manufacturing and analytical services available in Harleysville PA. Stand alone 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, flexible, are all qualities to look for. Altasciences is a mid size, forward thinking CRO that has all the scientific expertise to meet your needs, with a fully integrated preclinical to clinical offering, including expert bioanalysis, small molecule manufacturing and analytical services, and more. https://www.altasciences.com/blog/making-most-your-cro-partnership

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 to us, and to you. Read more about our approach to successful regulatory audits here: http://www.altasciences.com/sites/default/files/flipbook/20190529/index.html?page=12

How does Altasciences ensure an integrated approach for their comprehensive services?

Our vision is to provide our 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 outstanding, 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 our sponsors. Recently, we have expanded our services to include comprehensive preclinical services, and manufacturing and analytical services for small molecules. Our teams, from senior management to bioanalytical labs to preclinical and clinical trial services operations, and every position in between, have vast and broad industry experience from CROs, biopharma and pharma, academia, government, and other industry sectors.

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Working as a flexible, attentive extension of your team, we offer all you need to move your molecule forward.