Phase 1 Clinical Trials & Early Phase Clinical Research
Innovative End-to-End Solutions for Phase 1 Clinical Trials
Clinical trial complexity has strikingly escalated during the last decades, including a surge in the number of performed procedures, associated costs, and administrative load. Phase 1 clinical trials pose an especially significant challenge due to the requirements for extensive safety monitoring and correlative testing and the high failure rate of developmental drug candidates.
BioPharma Services Inc. offers end-to-end solutions for Phase 1 clinical trials ranging from clinical trial design and execution to data reporting and tabulation and the preparation of a final Clinical Study Report. In addition, we have niche expertise in a number of study areas.
Robust Clinical Trial Design
BioPharma Services has been instrumental in the completion of more than 2,000 clinical trials. Our experienced physician team, state-of-the-art facilities, large database of healthy volunteers, and transdisciplinary expertise — including extensive experience in the fields of pharmacology, bioanalysis, statistics, and regulatory sciences — enable us to effectively design and conduct even the most complex clinical trials.
Unparalleled Physician Team
BioPharma Services physicians have dedicated their professional careers to advancing healthcare and providing innovative medical solutions to our communities. We have crafted an accomplished medical team that can be your trusted partner in creating leading-edge healthcare solutions and essential medical therapies. Our unique physician network and our flexible approach allow BioPharma to take on even the most challenging studies.
A Large Database of Healthy Volunteers and Special Populations
Challenges with participant recruitment are an important reason for the delay or failure of clinical trials. The BioPharma Services team has worked tirelessly for more than 15 years to establish a reliable and compliant database of healthy subject volunteers and special populations that enables the seamless execution of Phase 1 trials.
Moreover, volunteer safety is our team’s highest priority throughout each trial. 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.
BioPharma Services owns state-of-the-art Phase 1 centers in Toronto, Canada, and St. Louis, Missouri, that provide the necessary infrastructure to support our global clients’ early phase drug development program needs. We also have an in-house bioanalytical laboratory that can conduct diverse bioequivalence (BE) and bioavailability (BA) studies.
Transdisciplinary Expertise and a Collaborative Approach
Our medical team collaborates closely with our specialists across various functional areas, including statisticians, regulatory scientists, pharmacologists, and pharmacokinetic scientists to ensure efficient clinical trial design and conduct.
Competent statistical support
Complete alignment with regulatory requirements
Pharmacological and bioanalytical expertise
Extensive experience with pharmacokinetic studies
- Competent statistical support. Our team of talented statisticians and programmers aids the development of robust clinical trial designs that reduce/eliminate study bias and ensure efficient data collection and analysis.
- Complete alignment with regulatory requirements. BioPharma’s experienced regulatory scientists ensure that all aspects of clinical trial design and conduct are aligned perfectly with regulatory requirements and can even support clients at regulatory meetings.
- Pharmacological and bioanalytical expertise. BioPharma works with a team of accomplished pharmacologists and bioanalytical scientists who rely on innovative strategies to meet the complex needs of our clients. We have the capabilities to develop novel assays and evaluate atypical administration and sample collection routes. Moreover, BioPharma’s in-house bioanalytical laboratory performs liquid chromatography with tandem mass spectrometry (LC/MS/MS) analysis in different matrices. Notably, we can successfully analyze clinical trial samples to support First-to-File Abbreviated New Drug Application (ANDA) submissions to the US FDA.
- Extensive experience with pharmacokinetic studies. Our pharmacokinetic scientists establish the safe and effective therapeutic doses and administration routes for the drug candidates of our clients. Notably, our talented pharmacokinetic team has developed thousands of innovative study designs and has supported drug submissions to multiple regulatory markets across the globe.
Schedule a Discovery Call
If you are looking for a full-service Clinical Research Organization (CRO) with an innovative, solution-oriented mindset, schedule a meeting to discover how partnering with BioPharma can be the answer to the problems you did not know you had! Complete the form below to schedule a Discovery Call with one of our medical team to learn how BioPharma Services can be your trusted clinical trial partner.
Experience in a Variety of Study Types
In addition to Phase 1 clinical trials, BioPharma Services’ team also conducts pharmacokinetic-pharmacodynamic studies, Human Abuse Potential and Abuse Deterrent Assessments, Bioequivalence/Bioavailability studies, Good Laboratory Practices (GLP) research, and development and sample analysis. Besides, our diverse expertise has enabled us to undertake complex studies in cutting-edge areas, such as gene therapy and interventional radiology.
We can provide support in the following areas:
- First in Human (FIH)
- Single Ascending Dose (SAD)/Multiple Ascending Dose (MAD)
- Absolute bioavailability
- Safety and Tolerability
- Food Effect study
- Age and gender
- Dose proportionality
- Drug-Drug and Alcohol interaction studies
- Human Abuse Potential/Abuse Deterrent Assessment
- Medical Cannabis
- Pharmacokinetics/Pharmacodynamics (PK/PD)
- Exploratory clinical models for Proof-of-Concept decision making
- BA/BE for all dosage forms (including solid oral formulations, transdermal patches, inhalation products and depot injections)
Personalized service and short turnaround times
At BioPharma Services, we apply a personalized approach to each project to meet the individual needs of our clients.Our organization distinguishes itself with fast decision-making, agility, and excellent problem-solving skills.
We deliver results within short turnaround times to accelerate the drug development process.