BioPharma Services Inc. is a global CRO specializing in Phase 1/2a, Human Abuse Liability, and Bioequivalence/Bioavailability studies. They offer comprehensive early-stage clinical research solutions to bring pharmaceutical products to market.
BioPharma Services Inc. is a full-service, regulatory-inspected Contract Research Organization (CRO) with extensive experience in early-stage clinical research, including Phase 1/2a, Human Abuse Liability, and Bioequivalence/Bioavailability studies. They are dedicated to advancing medical science and improving patient lives by helping companies bring safe and effective drugs to market. With state-of-the-art facilities and a team of experienced medical physicians and research scientists, BioPharma Services offers a comprehensive suite of clinical trial solutions. Their expertise spans clinical trial design, data management, biometrics, medical writing, and bioanalysis. They have a proven history of regulatory inspections by major bodies like the US FDA, UK MHRA, and Health Canada, ensuring adherence to GCP and GLP standards. BioPharma Services boasts a large, compliant database of over 18,000 healthy subject volunteers and special populations, facilitating seamless participant recruitment for even the most challenging studies. Their commitment to quality, safety, and innovation makes them a trusted partner for pharmaceutical companies navigating the complex drug development process and seeking to bring first-in-world medicines to patients.
About
**Who they are** BioPharma Services Inc. is a global Contract Research Organization (CRO) specializing in early-stage clinical research, dedicated to advancing medical science and bringing pharmaceutical products to market. Founded by physicians with a vision for improving patient lives, the company emphasizes performance, quality, and innovation.
**Expertise & scope** * Phase 1 Clinical Trials: Design and conduct of early-phase studies, including First-in-Human (FIH), Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies. * Bioequivalence (BE) and Bioavailability (BA) studies: Comprehensive early-stage clinical research solutions. * Proof of Concept Studies: Early Phase II trials to assess efficacy, safety, and guide further development decisions. * Clinical Pharmacology Studies: Including human abuse potential, drug interaction, and food effect studies. * Specialized Study Designs: Food effect, drug interaction, gender, age, CNS drugs, dependence, and 505(b)(2) and NDAs. * Bioanalytical Services: In-house laboratory capabilities for diverse bioequivalence and bioavailability studies.
**Reputation / proof points** * Completed over 2,200 clinical trials for global partners. * Extensive database of over 18,000 healthy subject volunteers and special populations. * State-of-the-art Phase 1 center in Toronto, Canada. * Recognized with over 20 awards and recognitions.
Additional information
BioPharma Services Inc. emphasizes a multidisciplinary and collaborative approach to early-phase clinical research. Their team comprises clinical pharmacology scientists, pharmacokinetics scientists, clinicians, biostatisticians, data managers, and analytical laboratory scientists, ensuring comprehensive oversight. The company highlights its robust participant recruitment process, with a database of over 18,000 healthy volunteers and special populations, designed to facilitate seamless execution of Phase 1 trials. Volunteer safety is consistently prioritized throughout all study phases, with a comprehensive strategy for risk assessment and mitigation in place prior to study initiation.
Key Highlights
BioPharma Services Inc. has successfully completed over 2,200 early-phase clinical trials.
Source
“BioPharma Services has been instrumental in the completion of more than 2,200 human clinical trials.”
Maintains a database of over 18,000 healthy subject volunteers and special populations for trial recruitment.
Source
“Our volunteer database currently encompasses 18,000-plus active subject participants, including healthy males and females; recreational drug users (opioids, cannabinoids, and stimulants); and age- and gender-restricted populations.”
Offers expertise in a wide range of early-stage clinical trial designs, including FIH, SAD, MAD, BE, and BA studies.
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“These early phase studies include first-in-human and Phase 1 clinical trials and single and multiple ascending dose study designs.”
Recognized with over 20 awards and recognitions for accomplishments in clinical research.
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“BioPharma’s accomplishments in clinical research have been acknowledged with more than 20 awards and recognitions.”
Certifications & Trust Signals
Founded by physicians dedicated to advancing medical science.
Source
“Founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients.”
Operates a state-of-the-art Phase 1 center in Toronto, Canada, with an in-house bioanalytical laboratory.
Source
“BioPharma Services owns a state-of-the-art Phase 1 center in Toronto, Canada that provide the necessary infrastructure to support our global clients’ early phase drug development program needs.”