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 Phase 1 Clinical 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.
Early Stage Clinical Trials:
A Prerequisite for Late Stage Clinical Research
First-in-Human Trials
First-in-human clinical trials include the first administration of NCEs and IMPs in humans to determine a safe dose range that also has the potential for pharmacological activity. First-in-human studies are challenging due to the complexity and inherent risks associated with extrapolating preclinical data to design a study involving humans.
At BioPharma, we efficiently and competently design and conduct first-in-human studies for the initial administration of IMPs and NCEs in humans. Based on the preclinical datasets of our clients, we help them select a safe first dose. We identify a dose range that is safe to administer in further trials, but is also capable of exerting a pharmacological activity.
When reviewing our clients’ preclinical datasets and designing a first-in-human trial, we provide comprehensive feedback and recommendations regarding all safety aspects of the study.
Phase 1 Clinical Trials
Phase 1 clinical trials investigate the safety and tolerability of NCEs and IMPs. Their study design has become increasingly complex, requiring extensive safety monitoring. At BioPharma, we have the skills and expertise to design and conduct even the most complex Phase 1 clinical trials to collect comprehensive data on the safety and tolerability of IMPs and NCEs and to gain insight into their pharmacokinetic properties.
In addition to the Primary Safety Assessment, we are able to include pharmacological or safety-related secondary endpoints based on the expertise of our multidisciplinary team.
The information gathered during the Phase 1 clinical study is used for the design of Phase 2 clinical trials.
Single Ascending Dose or Multiple Ascending Dose Study Designs
Within Phase 1 trials, Single Ascending Dose (SAD) study designs enable the identification of a safe dose range and the detection of common side effects.
BioPharma’s multidisciplinary team helps study sponsors select the optimal first dose and dosing schedule for single ascending dose studies while maintaining appropriate dosing intervals to ensure participants’ safety. A multiple ascending dose study may be conducted subsequently or in parallel with the single ascending dose trial.
Single and Multiple Ascending Dose (MAD) studies are designed as randomized, placebo-controlled trials that are most commonly conducted on healthy normal volunteers (HNVs).
Pharmacokinetic Studies in the Context of Phase 1 Trials
BioPharma’s team assists study sponsors in selecting appropriate pharmacokinetic timepoints for early phase clinical trials. We examine the preclinical datasets of our clients and use pharmacokinetic modeling to model the dosing for a subsequent multiple ascending dose study. In addition, we collect valuable information on the pharmacokinetic characteristics of IMPs and NCEs.
Phase 2A Clinical Trials
Based on the findings of Phase 1 clinical trials, we design and conduct Phase 2A clinical trials to collect initial data on the biological activity of IMPs and NCEs.
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.
Pharmacodynamic Endpoints:
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.
Full-Service CRO Approach Streamlines Early Phase Clinical Research
BioPharma Services comprehensively supports our clients, including fully integrated strategic and scientific guidance, protocol development, safety monitoring, state-of-the-art bioanalysis, pharmacokinetic and pharmacodynamic evaluations, expert project and clinical trial data management, and regulatory guidance.
Our Multidisciplinary Team
Includes physicians, pharmacologists, laboratory scientists, statisticians, and regulatory affairs specialists, who collaborate closely to successfully design and conduct all aspects of early stage clinical trials.
Complete Regulatory Alignment
BioPharma’s expert regulatory team is involved in the design and conduct of early stage clinical trials to ensure perfect alignment with the requirements of regulatory agencies — and we can support clients at regulatory meetings.
Competent Statistical Support
Our PhD-level team of statisticians and programmers performs statistical analysis plan (SAP) development, safety data management, and medical coding to ensure efficient data collection and analysis.
Bioanalytical Service Expertise
Our in-house bioanalytical laboratory is equipped with a liquid chromatography with tandem mass spectrometry (LC/MS/MS) platform to identify and quantify low-abundance analytes in a variety of matrices. Click to Learn More.
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. Janice Faulknor
Medical Director & Principal Investigator
Dr. Janice Faulknor has over 15 years of experience as a PI or sub-investigator of over 100 clinical trials in various therapeutic areas.
An Extensive Database of Study Volunteers
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.
State-of-the-art bioanalysis capabilities
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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