BioPharma Services
Streamlining All Aspects of Human Clinical Trials

BioPharma Services is a full-service contract research organization (CRO) specializing in conducting Phase 1/2a and bioequivalence clinical trials and helping companies run multiple parts and different cohorts of complex study designs simultaneously. It addresses the need to conduct multiple studies in one study design enabling biotech companies to complete more studies with fewer resources in less time.

BioPharma Services has clinical research facilities in Canada and the U.S. with a total capacity of 300 beds with access to healthy volunteers and special populations. BioPharma’s comprehensive services include bioanalysis at its GLP-certified laboratory, scientific and regulatory affairs, biostatistics and safety data analysis (CDISC), data management, and medical writing.

It helps clients take their compound from the protocol development stage to submission and regulatory agencies. Taking a client-focused, innovative thinking and pro-active approach along with transparent communication to solution delivery allows BioPharma to ensure expedited timelines for all services, including proven First-to-File services for US FDA drug submissions. It offers complete services from study design inception, clinical trial execution, data reporting, and tabulation to final clinical study report for Phase 1 clinical studies, human abuse potential and abuse-deterrent assessments, bioequivalence, and GLP R&D and sample analysis.

“Our focus on scientific collaboration and a personalized approach with clients allows us to conduct studies as per their expectations,” says John Oldenhof, executive VP of scientific affairs, BioPharma. “We partner with them to develop the best design for the study protocol and consider their needs for phase two and questions they expect to be answered.”

BioPharma Services’ strength lies in its diversity and experience. The team has vast experience across different sectors and takes a scientific and collaborative approach to each project.

“Our diverse team provides clients with a 360 view into their drug development process to ensure the successful launch of their product," says Dr. Janice Faulknor, medical director and principal investigator, BioPharma.

The diverse team includes Emergency Physicians, Anesthesiologists, Interventional Radiologists, and Anesthesiologists who support different procedures across various studies. Its PhD-level scientists and experts have over two decades of experience in phase 1 clinical research. They help clients develop their programs by identifying the areas of improvement to ensure the successful launch of their products.

In addition to working with sponsors in designing the study, they collaborate with the clinical sites to ensure the outcomes they are trying to achieve scientifically can be operationalized appropriately. They also test the assumptions made during the protocols. Its PK team, on the other hand, takes care of PK parameters and modeling. BioPharma Service’s team members also have around 20 years of experience in abuse liability assessment and deterrent formulations, making it a preferred CRO for sponsors.

BioPharma nurtures an inclusive and collaborative culture where individuals empower each other to excel in all facets of clinical research together and perform at their best to achieve greatness. It fosters the same culture and brand of excellence while working with clients and encourages them to work in partnership to achieve and celebrate success together as a team than as an individual.

Our diverse team provides clients with 360-view in their drug development process to ensure successful launch of their product

“We use our scientific and medical expertise along with our experience across different sectors to help clients on all aspects of development, including scientific and marketing points of view with their drugs,” says Dr Faulknor.

BioPharma understands the challenges of selecting the right CRO for its drug development program. To streamline this process, it guides clients at every step of the journey. From the first business development interaction or when clients contact BioPharma to schedule a discovery call, its scientific team gets fully involved. This helps scientists or PIs understand the client’s study status and goals.

BioPharma recently worked with a client to complete a psychedelic study for an oral formulation. The task was to create an appropriate dose escalation scheme and identify ways to assess if the participants were having a psychedelic experience. BioPharma guided them in each step, from selecting the patient population, mindful that the therapy would target naive subjects, to creating an environment within the clinic appropriate for the study. To ensure individuals being dosed have a seamless experience, it set a great ambience in the room with pleasant music and lighting.

In another case, BioPharma helped a client design an effective approach for a pilot study to develop an abuse-deterrent formulation. It narrowed down their requirements to obtain a clear understanding of what the client needed to invest further in this program. This helped create essential protocols to identify whether their approach would work or not. It ultimately designed a lean protocol that reduced price and ensured readiness for the study.

When it comes to quality and safety, BioPharma follows the highest industry standards and is inspected by all major regulatory agencies, including the U.S. FDA, UK MHRA, ANSM, WHO, DKMA, ANVISA, and Health Canada. It continually updates templates and SOPs and adheres to the latest protocols and processes to ensure improvement in quality, reliability, and trust in the data and overall approach to study designs and execution.

Focused on delivering quality services from protocol development to regulatory submission, this one-stop clinical trial services company aims to streamline all aspects of human clinical trials for clients.