Phase 1 Clinical Trial & Early Phase Clinical Research
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. Our 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:
- 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.