BioPharma Services Inc.
Toronto‑based regulatory‑inspected contract research organization (CRO) providing early‑phase clinical trial services (Phase I/IIa), bioequivalence/bioavailability and human abuse potential studies. Offers on‑site inpatient study conduct, in‑house bioanalysis, clinical data management with CDISC implementation, biostatistics/biometrics, medical writing, regulatory affairs, and participant recruitment via a maintained volunteer registry. In 2025–2026 the organisation disclosed and investigated a ransomware incident affecting some servers and announced follow‑up actions and regulatory notifications.
Industries
Nr. of Employees
medium (51-250)
BioPharma Services Inc.
Products
first human
Comprehensive early-phase clinical research services encompassing first-in-human administration of novel chemical or biological entities paired with single ascending dose designs and rigorous safety monitoring.
First in Human Studies (FIH)
Phase 1 clinical trials of new drugs involving initial human testing to determine the highest safe dosage without causing harmful side effects.
First-in-Human Trials
Design and conduct of initial administration studies of IMPs and NCEs in humans to determine safe dose ranges and pharmacological activity.
Phase
Early phase clinical research services conducted across a wide variety of therapeutic areas to ensure drug safety and efficacy.
Phase 1 Clinical Trials
Complex Phase 1 clinical trials to collect comprehensive safety, tolerability, and pharmacokinetic data on IMPs and NCEs.
Phase 2A Clinical Trials
Design and conduct of Phase 2A clinical trials to collect initial data on the biological activity of IMPs and NCEs.
first human
Comprehensive early-phase clinical research services encompassing first-in-human administration of novel chemical or biological entities paired with single ascending dose designs and rigorous safety monitoring.
First in Human Studies (FIH)
Phase 1 clinical trials of new drugs involving initial human testing to determine the highest safe dosage without causing harmful side effects.
First-in-Human Trials
Design and conduct of initial administration studies of IMPs and NCEs in humans to determine safe dose ranges and pharmacological activity.
Phase
Early phase clinical research services conducted across a wide variety of therapeutic areas to ensure drug safety and efficacy.
Phase 1 Clinical Trials
Complex Phase 1 clinical trials to collect comprehensive safety, tolerability, and pharmacokinetic data on IMPs and NCEs.
Phase 2A Clinical Trials
Design and conduct of Phase 2A clinical trials to collect initial data on the biological activity of IMPs and NCEs.
Services
End‑to‑end design and conduct of early‑phase clinical trials in an on‑site inpatient clinical research facility.
Design and conduct of BE/BA studies to support generic, hybrid and regulatory filings across jurisdictions.
Design and execution of abuse liability studies for controlled substances and cannabinoid products, including HAP‑specific data capture and assessment.
Assay development, sample extraction and validated quantitative testing using LC‑MS platforms with method validation and expedited turnaround.
EDC/eCRF implementation, CDISC‑compliant data standards, targeted data capture, data validation and biostatistical analysis support for clinical trials.
Preparation of clinical study reports, regulatory documents and other study‑related scientific writing to support submissions and communications.
End‑to‑end design and conduct of early‑phase clinical trials in an on‑site inpatient clinical research facility.
Design and conduct of BE/BA studies to support generic, hybrid and regulatory filings across jurisdictions.
Design and execution of abuse liability studies for controlled substances and cannabinoid products, including HAP‑specific data capture and assessment.
Assay development, sample extraction and validated quantitative testing using LC‑MS platforms with method validation and expedited turnaround.
EDC/eCRF implementation, CDISC‑compliant data standards, targeted data capture, data validation and biostatistical analysis support for clinical trials.
Preparation of clinical study reports, regulatory documents and other study‑related scientific writing to support submissions and communications.
Expertise Areas
- Phase I/IIa clinical trial management
- Bioequivalence and bioavailability study design
- Human abuse potential study methodology
- Bioanalytical assay development and validation
Key Technologies
- Liquid chromatography–mass spectrometry (LC‑MS)
- Validated bioanalytical assay methods
- Electronic data capture (EDC/eCRF) systems
- CDISC data standards
News & Updates
On 2025-11-20 servers were encrypted in a ransomware attack. An incident response was initiated, impacted systems were isolated and third‑party cybersecurity experts were engaged. Initially there was no evidence of personal health information exfiltration; on 2026-02-03 data from the November incident was discovered posted on a dark web site. The organisation's review identified impacted data types including participant name, home address, date of birth, email, phone number, gender, income, race/ethnicity and study screening/health information. The majority of affected participants were Ontario residents, with a small number from other provinces. The matter was reported to the Information and Privacy Commissioner of Ontario and to law enforcement; enhanced cybersecurity safeguards and ongoing monitoring were implemented. Contact for questions: privacy@well.company.
Participation at CPhI Worldwide (industry conference/exhibit).
Roles and contents of the Trial Master File (TMF) and Investigator Site File (ISF), alignment with ICH E6 and the DIA TMF Reference Model, and practices for maintaining inspection‑ready documentation.
Technical overview of Tmax interpretation in bioequivalence studies, regulatory approaches, sampling schedule considerations and alternatives such as partial AUC for early exposure assessment.
Published project materials listing bioanalytical assays completed across biological matrices and a record of generic compounds studied to support sponsor programs.
Discussion of targeted data capture strategies and precision in data collection for human abuse liability research to inform risk assessment and outcomes.
On 2025-11-20 servers were encrypted in a ransomware attack. An incident response was initiated, impacted systems were isolated and third‑party cybersecurity experts were engaged. Initially there was no evidence of personal health information exfiltration; on 2026-02-03 data from the November incident was discovered posted on a dark web site. The organisation's review identified impacted data types including participant name, home address, date of birth, email, phone number, gender, income, race/ethnicity and study screening/health information. The majority of affected participants were Ontario residents, with a small number from other provinces. The matter was reported to the Information and Privacy Commissioner of Ontario and to law enforcement; enhanced cybersecurity safeguards and ongoing monitoring were implemented. Contact for questions: privacy@well.company.
Participation at CPhI Worldwide (industry conference/exhibit).
Roles and contents of the Trial Master File (TMF) and Investigator Site File (ISF), alignment with ICH E6 and the DIA TMF Reference Model, and practices for maintaining inspection‑ready documentation.
Technical overview of Tmax interpretation in bioequivalence studies, regulatory approaches, sampling schedule considerations and alternatives such as partial AUC for early exposure assessment.
Published project materials listing bioanalytical assays completed across biological matrices and a record of generic compounds studied to support sponsor programs.
Discussion of targeted data capture strategies and precision in data collection for human abuse liability research to inform risk assessment and outcomes.