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Phase 1 Clinical Trial & Early Phase Clinical Research

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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.

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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.

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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.

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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.

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Transdisciplinary & Collaborative Approach

Unrivaled global medical expertise

Our medical team coallaborates 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. 

Interested in Phase 1 Studies? We think you’ll enjoy these links.

We apply a Personalized Approach to each project

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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:

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Phase1 FAQ

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    What is a Phase 1 Clinical Trial?

    What is a phase 1 clinical trial? The first clinical studies in humans are often referred to as Phase 1 clinical studies or Early Phase Studies. They are typically conducted during the early drug development phase, however, clinical pharmacology studies (e.g. drug-drug interaction, thorough QT studies, renal insufficiency, hepatic insufficiency and human abuse potential studies) may be conducted later in the drug development process while the Phase 2 and Phase 3 studies are being conducted. The focus of Phase 1 studies is on safety, pharmacokinetics and may also be on the pharmacology of the drug, but the efficacy is not directly being assessed.

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    What Happens During a Phase 1 Clinical Trial?

    During Phase 1 clinical studies, the drug is administered to subjects. This may be done as a single dose or in multiple doses over a period of days. The volunteers are repeatedly assessed for safety (adverse events, laboratory values, vital signs, ECG’s) and blood concentrations over time (pharmacokinetics). Generally, the efficacy of the drug is not directly assessed even if the drug is given to patients. Biomarkers or pharmacologic effects may be assessed. Most of the time, volunteers in Phase 1 studies stay several nights in a clinical pharmacology unit so that the volunteers can be closely monitored.

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    Who Regulates Phase 1 Clinical Trials?

    Phase 1 studies are regulated by the same authorities that regulate Phase 2 and 3 studies. The studies should be submitted to the authority in the country that the study is being conducted in, but may also be submitted to the country that the sponsor intends to file the submission with. For example, a Phase 1 study to be conducted in Canada needs to be submitted to Health Canada with a Clinical Trial Application (CTA). The sponsor may elect to also submit the Phase 1 protocol under an IND to the FDA in the United States. Note, however, it is sufficient to submit the protocol to the country that the study is being conducted.

    In the case of the FDA, the sponsor may elect to have their pre-IND meeting or file the IND until after the Phase 1 study data is available. This has the advantage of shifting the discussion with the FDA from what will the Phase 1 study look like, what is the safe starting dose and what safety monitoring is appropriate to what the Phase 2 program should look like.

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    How Long Does a Phase 1 Clinical Trial Take/Last?

    The clinical conduct portion of the Phase I study last from weeks to months. For a single ascending dose escalation study, there is a screening period of up to a month prior to dosing. Dosing between cohorts can be 1 to 2 weeks. The follow-up is likely around 2-3 weeks. So for a 5 cohort SAD study, the clinical conduct may take 3 to 4 months.

    The pre-study activities including protocol development, submission, regulatory and ethics review and approval and start up activities can be 2 to 5 months. The post study activities after data is collected from the last subject at their last visit to a first draft of the clinical study report generally take 3 months, but can expedite based on needs. During this period the data is entered, reviewed and monitored in the database. The database is locked and tables, listings and figures are generated to inform the clinical study report. Then the scientists and medical writers interpret the data and summarize this in the clinical study report.

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    Why Are Phase 1 Clinical Trials Important to Drug Development?

    The first-in-human (FIH) study is the first Phase 1 study completed in humans. It helps to characterize the drug effect in humans. It helps to characterize the safety profile and safety issues, and it helps define doses that are considered safe to study in subsequent studies. Likewise, it also helps to understand the pharmacokinetic properties of the drug, including the maximum concentration, time to maximum concentration, maximum concentration and the elimination characteristics.

    These studies help to define appropriate doses and dosage regimes to use in the Phase 2 studies. Phase 1 clinical pharmacology studies help to understand important properties of the drug that will be summarized in the approved drug label or product monograph. This includes whether those with renal or hepatic impairment eliminate the drug differently, whether the drug interacts with other drugs, or does the drug have the potential to produce arrhythmias.