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Where Innovation, Science & Spirit Intersect

We are a full-service regulatory-inspected Contract Research Organization specializing in Phase 1/2a, Human Abuse Liability and Bioequivalence/Bioavailability studies. Discover the BioPharma difference.

Volunteers

Getting a new drug onto the market is a process that can take many years. BioPharma Services helps companies ensure that drugs that are being developed are safe and effective. Take a look at our Frequently Asked Questions and other volunteer pages to learn more about how you can become involved by participating in a Clinical Trial.

Sponsors

Led by an expert panel of experienced Medical Physicians and Research Scientists, BioPharma has built a full suite of clinical trial solutions from Phase I to BE/BA services to assist our clients’ clinical drug development programs.                                                                                                                                                                                                     

We Bring Pharmaceutical Products To Market

The team at BioPharma Services is dedicated to bringing novel therapies to the market through high quality medical research.  Founded by the vision of two surgeons dedicated to advancing medical science and improving the life and quality of their patients, we brought life to BioPharma. It is with this same culture and brand of excellence that we welcome our clients. 

BioPharma Services Brings Pharmaceutical Products To Market Hero Image.

Our
Services

Along with our core clinical competency of flawless execution of Phase I, BE/BA and Human Abuse Potential studies, complementary support services are available to align with our clients’ clinical trial needs.

As a full-service contract research organization, our service offering includes: Scientific, Medical and Regulatory Affairs, Bioanalysis, Clinical Trial Data Management, Biometrics (CDISC compliant data standards), Medical Writing and long-term archiving of study documents.

 

Why
BioPharma

At BioPharma, we appreciate the dynamic and complex regulatory landscape that governs the drug approval process. Let’s work together to combine our knowledge, expertise, and know-how to navigate our way through the clinical development process and bring first-in-world and affordable medicines to every individual patient in need. With competence and compassion, we as a contract research organization, aim to earn the trust and respect of our global clients, employees, and patients.

 

Quality and
Governance

In this highly regulated industry that is governed by the international quality standards of GCP and GLP, it is paramount that our processes, quality and governance never falters. With strong adherence to the principles set forth by the ICH, BioPharma’s unwavering commitment to CRO research quality and safety standards is supported by our history of regulatory inspections that spans across markets. This includes routine regulatory inspections by the US FDA, UK MHRA, ANSM, DKMA, ANVISA and Health Canada and a GLP certification by the SCC.

Clinical Trial Services

State of the art facilities. World class leaders. Innovative scientific expertise

Support Services

To ensure the successful submission of every trial, BioPharma offers a full suite of Support Services.

Clinical Trial Services

State of the art facilities. World class leaders. Innovative scientific expertise.

Phase 1 & 2a

We collaborate with global pharmaceutical companies, making sure their program needs for early phase drug development are more than satisfied. BioPharma conducts Phase 1 clinical trials across a wide variety of therapeutic areas.

Phase 1 & 2a ➞

Bioanalysis

Delivering high quality, accurate and innovative solutions to support the drug development programs of our clients.

Bioanalysis

Human Abuse Potential

BioPharma has amassed extensive experience in the conduct of clinical studies in opioids, narcotics and cannabinoid products. These studies help drug developers understand their product’s potential risk for abuse before seeking regulatory approval.

Human Abuse Potential

Bioequivalence

BioPharma has built a brand of excellence in the conduct of Bioequivalence (BE) and Bioavailability (BA) studies to support both generic and hybrid drug filings and 505(b)(2) New Drug Applications.

Bioequivalence & Bioavailability

Support Services

State of the art facilities. World class leaders. Innovative scientific expertise

Data Management

Efficient, cost-effective services in a timely, expeditious manner packaged to meet the current regulatory and industry standards.

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Medical Writing

Our Medical Writing team ensures clear communication between subjects, sites, sponsors and regulatory agencies.

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Biometrics/CDISC

With CDISC standards in mind right from data collection, BioPharma offers a suite of biostatistical services.

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Scientific Affairs

Our in-house experts have experience over a diverse range of clinical drug development programs for multiple therapeutic areas.

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Pharmacokinetics

Under the leadership of Chief Scientific Officer, Dr. John Oldenhof, the PK team have generated thousands of study designs to support drug submissions to multiple regulatory markets.

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Recruitment

A fundamental element of success for any clinical trial is subject recruitment. Our extensive database of engaged healthy volunteers includes special populations.

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Why BioPharma?

It’s our people, our culture and our community.

Our People

Two surgeons dedicated to advancing clinical science to improve patient outcomes founded BioPharma over 15 years ago. Today, our expanded team of multidisciplinary experts works together, building on this entrepreneurial foundation with common goals and values. We aim to exceed your expectations with our proactive approach and “can do” attitude.

Welcome to BioPharma! We look forward to working with you.

Our Clinics

With a state-of-the-art clinical facility with a total combined 150-bed capacity in Toronto, Ontario, BioPharma Services has conducted approximately 2,500 bioequivalence and Phase I clinical trials and counting. We have experience conducting Phase I trials across a wide range of therapeutic areas, including neurology, cardiology, immunotherapies and infectious diseases.

Our Labs

Led by experts with over 20 years of expertise, our Bioanalytical Lab in Toronto is equipped with the latest LC/MC/MS platforms to meet the demand for detecting increasingly lower amounts of drugs in biological samples. We develop novel assays and extraction methods that deliver consistent, accurate results on expedited turnaround times.

Recruitment

A fundamental element of success for any clinical trial is subject recruitment. Our extensive database of engaged healthy volunteers includes special populations.

CDISC Data Standards

CDISC data standards are becoming standard for all phases of clinical drug development and submissions to the FDA. We have the latest Biometrics Technology to ensure the successful submission of your application.

 

 

505(b)(2) NDA

This FDA New Drug Application can be an effective regulatory pathway for new products with well-understood active ingredients. Let us guide you through the process.

Pharmacokinetics

The movement of a drug into, through, and out of the body is a fundamental component of the clinical drug development process. Our expert Pharmacokinetic Scientists have solutions for all drug programs.

Our World Class Management Team

Our world-class team maximizes your results through collaboration.

Anna Taylor BioPharma Services

ANNA TAYLOR

Managing Director
Dr. John Oldenhof BioPharma Services

DR. JOHN OLDENHOF

Executive VP of Scientific Affairs
Renee John Biopharma Services Headshot image May 2023.

RENEE JOHN

Executive VP of Clinical Operations

Here's Some Of
Our Achievements

30+

Regulatory Inspections

2,000+

Completed Trials

20+

Awards and Recognitions

Contact Us

Corporate Office, Research Clinic & Bioanalytical Facility

4000 Weston Road, Toronto, Ontario M9L 3A2, Canada
Tel: +1 (416) 747-8484

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