Phase 1 Clinical Trial & Early Phase Clinical Research
Clinical Trial Design
We’ve completed more than 2,000 clinical trials for our global partners.
BioPharma Services has been instrumental in the completion of more than 2,000 human 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 phase 1 clinical trials.
Unparalleled Physical Team
Our physician team network can tackle the most challenging studies.
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 first in human studies.
Large database of Healthy Volunteers
More than 18,000 participants of all demographics.
Challenges with participant recruitment are an important reason for the delay or failure of phase 1 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 clinical trials.
Moreover, volunteer safety is our team’s highest priority throughout each FIH 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.
State-of-the-art Research Facilities
Phase 1 centers in the US and Canada with bioanalytical lab.
As a phase 1 company, 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 & Collaborative Approach
Unrivaled global medical expertise
Our medical team collaborates closely with our specialists across various functional areas, including statisticians, regulatory scientists, pharmacologists, and pharmacokinetic scientists to ensure efficient phase 1 clinical trial design and conduct.
We apply a Personalized Approach to each project
Competent Statistical Support
Our team of talented statisticians and programmers aids the development of robust Phase 1 clinical trial designs that reduce/eliminate study bias and ensure efficient data collection and analysis.
Complete Regulatory Alignment
BioPharma’s experienced regulatory scientists ensure that all aspects of Phase 1 clinical trial design and conduct are aligned perfectly with regulatory requirements and can even support clients at regulatory meetings.
Pharmacological and Bioanalytical Services.
BioPharmas capabilities to develop novel assays and evaluate atypical administration and sample collection routes. BioPharma’s in-house bioanalytical laboratory performs liquid chromatography with tandem mass spectrometry (LC/MS/MS) analysis in different matrices and successfully analyze clinical trial samples to support First-to-File Abbreviated New Drug Application (ANDA) submissions to the US FDA.
Pharmacokinetic First in Human Expertise
Our pharmacokinetic scientists establish the safe and effective therapeutic doses and administration routes for the drug candidates of our clients. Our pharmacokinetic team has developed thousands of innovative Phase 1 study designs and has supported drug submissions to multiple regulatory markets across the globe.
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 of first in human trials such as 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 phase 1 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 such as bioequivalence and bioavailability studies.
Experience in a Variety of Study Types
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. 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)
Schedule a Discovery Call
Learn how BioPharma Services can be your trusted clinical trial partner.