Early Stage Clinical Trials
Early Phase Clinical Research is a critical step in the drug development process, during which data on the safety, tolerability, pharmacokinetics, and biological activities of New Chemical Entities (NCEs) or New Investigational Medicinal Products (IMPs) are acquired. The findings of early phase clinical trials are critical because they are an absolute prerequisite for deciding whether IMPs and NCEs should proceed to advanced-stage clinical trials.
The design and conduct of early phase clinical studies are complex and challenging. A variety of factors related to the study design, participant characteristics, study power, data analysis, clinical pharmacology, bioanalysis, and regulatory aspects, should be considered.
Early stage clinical trials are associated with inherent risks and uncertainties and require extensive safety monitoring and an adaptive study design. The successful design and completion of early stage clinical trials require multidisciplinary expertise and alignment among the study team members.
Early Stage Clinical Trials Services and Design
BioPharma’s team has extensive expertise in early phase clinical research, including a wide range of studies. We efficiently and competently design early stage clinical trials, whose successful completion is a prerequisite for the transition of NCEs and IMPs into late phase clinical research. These early phase studies include first-in-human and Phase 1 clinical trials and single and multiple ascending dose study designs.
We also have extensive expertise in clinical pharmacology studies classified as Phase 1 clinical trials, but can also be performed simultaneously with Phase 2 and 3 trials. These studies are a prerequisite for New Drug Application (NDA) submissions, including human abuse potential (HAP), bioequivalence (BE) or bioavailability (BA) to bridge to early formulations in the drug development process, drug interactions, alcohol interactions, and food effect studies.
Clinical Pharmacology Phase 1 Trials
Human Abuse Potential and Abuse-Deterrent Assessments
We competently support our clients’ HAP and Abuse-Deterrent Assessment studies for all classes of central nervous system (CNS) compounds, including antidepressants, analgesics, stimulants, anticonvulsants, anesthetics, and Antiparkinsonian agents.
Innovative Assays for the Bioanalysis of Novel Compounds
We have the capabilities and expertise to develop innovative bioanalytical assays for IMPs and NCEs. To streamline and facilitate bioanalysis, we have established a state-of-the-art, in-house bioanalytical laboratory.
Drug Interaction and
Food Effect Studies
We have expertise in developing study designs for the analysis of the effect of food on drug absorption from a certain formulation. Moreover, we design studies to evaluate the potential of investigational drugs as inducers, inhibitors, or substrates of metabolizing enzymes or transporters.
Biomarkers and Cognitive Data
To advance the understanding of study drugs, our team can help select pharmacodynamic trial endpoints, including biomarkers or cognitive endpoints.
Bioequivalence (BE) studies
We have expertise in bioavailability BA/BE studies for all dosage forms (including solid oral formulations, inhalation products, transdermal patches, and depot injections). In addition, our team can support filings for generic and hybrid drugs and 505(b)(2) New Drug Applications. These studies are important to assess the PK profile of the final formulation against earlier formulation(s) so that the studies results of those earlier studies can be demonstrated to be applicable to the final formulation to be marketed.
BioPharma’s Vast Professional Expertise
BioPharma Services, Inc. has extensive expertise in conducting all early-phase clinical trials, with more than 250 multidisciplinary experts on our team, at least 8 of whom are Ph.D. graduates. Our cumulative experience of our principal investigators (PIs) exceeds 50 years as we have established a culture of excellence that prioritizes fast decision-making, a client-centered approach, and excellent problem-solving skills, enabling us to shorten turnaround times and accelerate the drug development process. We boast niche expertise in designing and conducting early stage clinical trials and HAP studies.
Dr. John Oldenhof
Chief Scientific Officer & Executive VP of Scientific Affairs
Dr. Oldenhof has over 18 years of senior management experience in Phase 1 clinical pharmacology, product development, biostatistics, data management, and regulatory and scientific affairs.
Dr. Fathi Abuzgaya
Chief Medical Officer & Principal Investigator
Dr. Fathi Abuzgaya has over 15 years of experience as a Principal Investigator(PI) or sub-investigator of over 100 clinical trials in various therapeutic areas.
BioPharma Services has established a large database of study volunteers, including over 18,000 HNVs and individuals from special populations. The strong rapport that we have established with our study volunteers greatly facilitates the recruitment for our clients’ clinical trials. Our recruitment procedure is comprehensive and sets participants’ safety as our top priority.
Our in-house bioanalytical laboratory analyzes biological samples from bioequivalence and bioavailability bioequivalence/bioavailability and clinical pharmacokinetic studies. Our bioanalytical team performs state-of-the-art liquid chromatography with tandem mass spectrometry (LC/MS/MS) analysis to confirm and quantify low-abundance analytes in a variety of matrices.
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