In addition to its Phase I/IIa capabilities BioPharma Services Inc. specializes in Bioequivalence & Bioavailability clinical trials, featuring:

Our BA/BE Expertisebe3

Through the expertise of our highly trained and experienced team of investigators and scientists, BioPharma has successfully conducted over 600 Bioequivalence/Bioavailability clinical trials across various therapeutic areas and dosage forms under Fed, Fasting as well as Multi-does conditions:

Bioanalytical Laboratory Services

Strategically housed in the same facility as our 180 bed Toronto Clinical Unit, BioPharma’s state of the art Bioanalytical Laboratory is GLP certified by the Standards Council of Canada and has been inspected by FDA, MHRA, ANVISA as well as Health Canada. We provide fast and reliable bioanalysis, backed by our proven comprehensive Quality Assurance System. Our laboratory services include:

The BioPharma Advantage

Clinical Sites:be4

Toronto, Canada

  • Centrally located and easily accessible via 3 major highways and 24 hr public transportation
  • 50,000 square foot (4,600 m2) facility
  • 180-beds across 5 Clinical units
  • Stand-alone 16-bed Phase 1 ICU
  • On-site Pharmacy / Controlled substance license
  • On-site Bioanalytical Laboratory
Columbia, Missouri

  • Strategically located in close proximity of the Boone County Hospital, Women’s Hospital and University of Missouri
  • 14,000 square foot(1,200 m2) facility
  • 70-bed Clinical unit
  • On-site Pharmacy / DEA license for administration and storage of controlled substances
  • Electronic data capture capabilities

Subject Database

Our robust subject database includes more than 30,000 normal healthy volunteers, including a variety of special populations:

Healthy Volunteers (~30,000):

  • 52% males, 48% females
  • Racially diverse
  • 91% Non-smoking
  • Geriatric
Special Populations:

  • Post-menopausal and surgically sterile females (3000+)
  • Hypogonadal and vasectomized males
  • Restricted BMI (including obese populations)
  • Fast/Slow metabolizers

In addition to our volunteer database, BioPharma has access to a large global physician network within a number of therapeutic areas; specializing in musculoskeletal (RA/OA), hematology (clotting), pain management, oncology and women’s health:

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Support Services

Led by a central Project Management Team, BioPharma offers comprehensive oversight and support for each clinical trial from beginning to end. Our services include study design, protocol development, regulatory affairs, scientific and medical oversight, pharmacodynamics and safety data analysis, data management, CRF/eCRF development, SDTM, ADaM and CDISC datasets, pharmacokinetics and biostatistics, generation of the final clinical study report.  Depending on each client’s individual needs, services may be tailored to suit the project requirements.