Phase 1 Clinical Trial Design
Learn more about our Phase 1 Clinical Trial Design and what BioPharma Services can offer
Clinical trial complexity has escalated during the last decades, including a surge in the number of performed procedures, associated costs, and administrative load. Phase 1 clinical trial designs vary, but the goal for BioPharma Services, Inc.’s elite Research Team is to determine pharmacodynamics (PD), pharmacokinetics (PK), drug safety, and tolerability. We also specialize in investigating bioequivalence and bioavailability studies, single ascending dose, multiple ascending dose, food effect, drug interaction, gender, and age studies.
Our Expertise in Phase 1 Clinical Trial Design
Early Phase 1 trial designs help determine how best to administer new treatments. The key points we at BioPharma Services focus on in our Phase 1 clinical trial design include, but are not limited to:
→ Analysis of what happens to the human body and drugs when they interact.
→ Monitoring, maintaining and troubleshooting clinical safety risks.
→ Our Research Team monitors volunteers and pays attention to serious side effects throughout. Because of the smaller study size, rare side effects are often not found until later.
→ Utilizing our burgeoning volunteer database with thousands of members to cater to any customizations needed for a study’s sample size.
→ Resolution of common challenges experienced with participant recruitment that can delay or fail out of Phase 1 clinical trials.
→ 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.
For your study, working with us as your primary Contract Research Organization (CRO) will allow you the creative freedom to design, build or expand your study to meet your requirements.
BioPharma Services caters to multiple different Phase 1 trial designs currently available. Our expertise and skill range widely. Furthermore, with thousands of active volunteers across Canada and the United States, BioPharma Services can handle any Phase 1 clinical trial design, scope, and multitude.
Types of Phase 1 Clinical Trial Designs
The 12 Different Phase 1 clinical trials BioPharma Services Inc. can work with you to design.
First in Human Studies (FIH)
Our Phase 1 clinical trials of new drugs involve human testing people first. For your Phase 1 ready trial, the treatment has already been conducted in a separate lab for animal studies; however, the human reactions to the drug are unknown. That’s where we at BioPharma come in. Our experienced Physician Team working in state-of-the-art facilities helps your team find out the highest dosage of new drugs that can be safely given without causing harmful side effects.
BioPharma’s dose-proportional studies are pharmacokinetics studies dedicated to determining the correlation between drug dose increases and their bioavailability. Our unique physician network and our flexible approach allow BioPharma to take on even the most challenging first in human studies for your team’s sake — ensuring quality, security, and safety.
Safety and Tolerability
While there is usually only one assessment of safety and tolerability in most clinical trials, we at BioPharma find this one of the most critical steps. Whether it is the early stages of safety and tolerability or later with a larger sample, volunteer safety is our team’s highest priority throughout each phase 1 clinical FIH trial. Furthermore, we employ stringent protocols for investigations of any compromised drug or volunteer safety.
Our expertly orchestrated multiple ascending dose escalation studies fully characterize the steady-state pharmacokinetics of the drug and its metabolites, investigate the potential for drug accumulation, examine its dose proportions, and determine the maximum tolerated dose (MTD). As MAD studies are the earliest trials conducted in a drug’s clinical development, our BioPharma team can carry out the single ascending dose study that comes before them.
When your study evolves from “single” to “multiple,” each subject is carefully monitored and given several doses of the investigational drug. As your trial progresses in our hands, the dosage increases with each new cohort of subjects. Our extensive experience in pharmacology, bioanalysis, statistics, and regulatory sciences enables us to effectively design and conduct even the most complex phase 1 clinical trial.
Human Abuse Potential & Abuse-Deterrent Assessment
Since the eruption of the opioid crisis, BioPharma got ahead and spearheaded Human Abuse Potential research. As such, with our highly trained and vetted researchers, physicians and writers, we have comprehensive experience with all CNS compounds. This includes:
- Antiparkinsonian Agents and more
The importance of product labeling and planning recommendations for new drugs is crucial to BioPharma phase 1 clinical trial design. With our team, we determine the potential abuse of your New Chemical Entity (NCE) based on a comprehensive analysis of chemical, pharmacological, clinical data, and drug-related public health risks.
Bioequivalence (BE) & Bioavailability (BA) Including Absolute Bioavailability
BioPharma bioequivalence (BE) and bioavailability (BA) studies studies are primary factors determining marketing approval applications. Our BEs compare the similarity between drugs with the same active ingredients, while our BA studies assess the ratio of drug absorbed and its subsequent release and excretion. Specifically;
- Absolute BA sub-studies compare the drug to intravenous concentrations of 100% BA.
- Relative BA sub-studies compare the drug to non-intravenous route’s BA concentrations.
The BioPharma Bioequivalence and Bioavailability Team collaborates closely with our talented bioanalytical scientists, statisticians, and regulatory professionals to comprehensively support all aspects of our clients’ bioequivalence and bioanalysis programs. Whether it is BA or BE, we at BioPharma can study all dosage forms, including solid oral formulations, transdermal patches, inhalation products and depot injections.
Drug-Drug and Alcohol Interaction Studies
As a phase 1 focused CRO, BioPharma Services owns and operates state-of-the-art phase 1 centers in Toronto, Canada, and St. Louis, Missouri. Our clinical research facilities provide the necessary infrastructure to support our global clients’ early phase drug development program needs. Drug-drug and alcohol interaction studies are crucial extensions of studies of metabolic pathways in vitro and in animals.
Pharmacokinetics (PK) / Pharmacodynamics (PD)
Led by Dr. John Oldenhof, BioPharma’s team of Pharmacokinetic scientists are experts in their field. Our team analyzes your therapy’s pharmacokinetics (PK) — the movement of a drug through the body — and pharmacodynamics (PD) — the body’s biological response to drugs. Understanding the drug compound’s basic PK and metabolism characteristics will eventually reveal the appropriate drug regimen for a patient. For this reason, we at BioPharma know that both are crucial to drug approval and continued development.
Exploratory Clinical Models for Proof-of-Concept Decision Making
Proof-of-concept (POC) studies are designed to provide preliminary evidence of efficacy and safety to guide transition decisions towards full drug development. Indeed, POC decisions are often based on if the desired effect size can be found compared to placebo or comparator drugs. You must be able to answer questions within a reasonable amount of time and within your allotted budget. And the study should be as small as possible.
BioPharma’s support with innovative early-stage clinical development plans, medical writing, pharmacokinetics, biometrics/CDISC, clinical trial data management and recruitment can get your study approval ready.
Age and gender
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 enable the seamless execution of phase 1 clinical trials. Our database has diverse ages and genders. Because genetic makeup, age and gender can affect the absorption, distribution, metabolism, and excretion (ADME) of compounds or their metabolites, studies solely dedicated to this component are crucial.
Similar to our Alcohol studies, BioPharma Medical Cannabis studies are extensions of preclinical in vitro and in vivo studies in which metabolic pathways have been identified. Our Scientific and 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.
Our BioPharma food-effect studies allow for a preliminary assessment of how compound intake is affected when given after a specially designed and standardized test meal. These studies are crucial for safety because the results are likely to aid label formulation. With BioPharma, we establish comprehensive data for your team’s drug that determines when best to administer the therapy relative to food intake to increase or decrease exposure.
Choosing a Phase 1 CRO e-book
How much does your Phase 1 trial mean to you? Learn more about the considerations for choosing the right Phase 1 Clinical Research Organization (CRO).
The Economical Design of Phase 1 Clinical Trials
Clinical trials are costly and time-consuming, and their results often require a lengthy approval process. However, with BioPharma Services, Inc.’s Pharmacology Support Team, from a cost perspective, your Phase 1 clinical trial design can be positively impacted by:
→ Carefully planned, intelligent study design protocols
→ Well-thought-out standardization of case report forms (CRF) design
→ Statistical programming
At BioPharma Services, flexible protocols allow you to achieve many goals with one protocol split into milestones. This method improves the efficiency of the drug development process and reduces the time it takes to prepare it for Phase 1.
Phase 1 research has the greatest potential risk. However, our well-structured phase 1 trial designs help get your therapy to patients sooner. BioPharma 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 preparation of a final Clinical Study Report.
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 Alignment with Regulatory Requirements
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.
We can assist you throughout the journey, including the New Drug Application (NDA) process. BioPharma’s Scientific and Medical team has extensive experience developing a 505(b)(2) product clinical development plan using the bridging PK/PD study approach. BioPharma also provides advice related to safety and efficacy assessments and the variety of clinical trials necessary for the 505(b)(2) pathway.
Pharmacological and Bioanalytical Services
BioPharma Services 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 U.S. Food and Drug Administration (FDA).
Extensive experience with
Pharmacokinetic First in Human Studies
Our pharmacokinetic scientists establish 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 Phase 1 clinical trial designs and has supported drug submissions to multiple regulatory markets across the globe.
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