First in Human (FIH) Studies

First in Human studies are the initial phase of clinical trials testing new drugs in humans, focusing on safety and tolerability. These are vital for deciding if a drug proceeds to further trials.

Partnering with BDD for your FIH studies offers you a blend of specialised clinical expertise, regulatory compliance, tailored client service, and a solid track record of study start and completion, ensuring your drug’s safe and effective advancement through early trial phases.

Choosing BDD for your First in Human (FIH) study is your best strategic decision

Expertise in Early-Phase Clinical Trials: BDD’s team possesses specialised knowledge and experience in conducting clinical studies, ensuring that your API is tested comprehensively and safely.
Commitment to Safety and Regulatory Compliance: BDD prioritises participant safety and adheres strictly to regulatory compliance, which is crucial for the successful approval and progression of your project.
Personalised Client Collaboration: BDD values close collaboration with our clients, offering tailored support throughout the FIH study process, from study design to implementation to clinical study report.
Proven Track Record: BDD’s history of successful clinical studies and satisfied clients speaks to its capability and reliability as a partner in drug development. By partnering with BDD for your FIH studies, you benefit from a combination of expertise, safety, innovation, and personalised care, ensuring your study is conducted with the highest standards and best chances for success.
MHRA Approved: BDD Provide FIH Principle Investigator (PI) for your study.

Providing clinical trial excellence for over two decades

BDD’s Comprehensive Offerings

Rigorous Safety Measures: Implementing strict protocols to protect trial participants. Based on site within the grounds of a large teaching hospital with immediate access to 24-7 cover from the hospital medical emergency team and within 10 minutes of an intensive care unit.

Detailed Pharmacokinetic Analysis: Through BDD’s preferred partners we offer PK analysis showing how a drug is absorbed & metabolized by the body.

Informed FIH Trial Design: Using BDD expertise to help and support with clinical trial design to maximise study success.

Strategic Dose Selection: We have an expert and experienced FIH PI who leads our team with dose selection and we regularly update & review with data review meetings. Leveraging our expertise to increase the likelihood of success.

Data management: BDD can offer in house data management services, can work with a Sponsor preferred EDC or introduce clients to our partner agencies. Through our partner agencies data can be provided in CDISC format if required.

Statistics: BDD can provide FIH and phase 1 statistical packages through partner agencies

Special Population Trials:

Healthy Volunteers and Patients: We conduct trials that span various populations, from healthy volunteers to specific patient groups such as those with respiratory conditions, diabetes, and gastrointenstinal diseases. This diversity in trial populations helps gather relevant data across different cohorts, providing a robust understanding of the investigational drug’s safety and efficacy.

Detailed Examples:

Elderly and Special Conditions: We have managed trials involving post-menopausal females, patients over 60, and individuals with chronic conditions such as COPD and type I Diabetes. Our tailored approaches ensure that these trials meet the unique needs of each population, providing insights that are critical for developing safe and effective treatments.

Emphasising Safety and Quality:
Safety and quality are paramount in our FIH trials. We implement rigorous risk management strategies, including continuous risk-benefit analysis and clearly defined stopping rules for individual subjects, cohorts, and the entire study. Our protocols are designed to ensure participant safety at every step, from initial dosing to follow-up assessments.

Regulatory Compliance and Engagement:
We maintain proactive engagement with regulatory agencies such as the MHRA to ensure our trials comply with the highest standards. Our team’s extensive experience in navigating regulatory landscapes ensures smooth and compliant trial processes, minimizing delays and optimizing outcomes.

Technological and Methodological Innovations:
We leverage advanced technologies and innovative methodologies to enhance the quality and reliability of our trial data. This includes the use of cutting-edge imaging techniques, such as gamma scintigraphy, and on-site laboratory capabilities that provide rapid, high-quality data analysis.

Adaptability

Adaptive Trial Designs

Our team excels in designing and conducting adaptive, multi-part trials. These trials are structured to allow flexibility and efficiency, adapting to emerging data without the need for additional regulatory approvals. This approach ensures a streamlined process, reducing delays and optimising the path to subsequent phases of clinical development.

Adaptive trial designs are crucial for early-stage clinical research as they provide the ability to modify the study protocol based on interim results. This can include adjustments to dosage, sample size, and patient cohorts, ensuring the trial remains responsive to real-time findings. Our expertise in this area ensures that we can deliver high-quality, adaptive FIH trials that meet your regulatory, scientific and commercial objectives.

Our adaptive protocols are designed to optimise trial designs, including single ascending dose (SAD), multiple ascending dose (MAD), and food effect studies. These protocols allow for flexible and efficient modifications based on real-time data, ensuring that our trials remain responsive and effective.

Example Implementation:

Multi-Part Adaptive Trials: Our recent trials have successfully incorporated adaptive designs, allowing for seamless transitions between different study parts, such as from single ascending dose (SAD) to multiple ascending dose (MAD) phases, while including patient cohorts when necessary. This method accelerates decision-making and enhances the efficiency of the clinical development process.

Risk Management

At BDD, participant safety is our top priority. Our comprehensive risk management strategies are designed to ensure the highest standards of safety throughout the trial process.

Continuous Risk-Benefit Analysis: We continuously evaluate the risk-benefit profile of our studies, ensuring that participant safety is maintained and that the potential benefits justify any risks involved. This involves regular reviews of trial data and close monitoring of any adverse events or unexpected findings.

Clear Stopping Rules: Our protocols include well-defined stopping rules that guide decision-making during the trial. These rules are in place for individual subjects, entire cohorts, and the overall study. They ensure that any safety concerns are promptly addressed, and appropriate actions are taken to mitigate risks.

Specific Strategies and Implementation:

Safety Monitoring: Throughout the trial, we perform extensive safety monitoring, including regular assessments of vital signs, electrocardiograms (ECGs), and clinical laboratory evaluations. This ensures that any adverse effects are quickly identified and managed.
Sentinel Dosing: For added safety, we employ sentinel dosing strategies where a small group of participants receives the initial doses before proceeding with larger cohorts. This helps identify any immediate adverse reactions and allows for timely adjustments.
Risk Assessment: BDD provide a multi-disciplinary, extensive, study specific clinical trial risk assessment for each project maximising safety, data integrity & success.
Above and Beyond Staff Training: We have an extensive roster of highly trained clinical staff including on site doctors and nurses. All our clinical staff have an excess of training (to intermediate life support training [ILS] certification. Exceeding the basic requirements of BLS training.

Regulatory Compliance

Our commitment to regulatory compliance ensures that all our trials adhere to the highest standards set by MHRA. We proactively engage with regulatory agencies to maintain compliance and facilitate smooth trial progression.

Proactive Regulatory Engagement: We maintain active communication with regulatory bodies throughout the trial process. This includes submitting detailed protocols for review, incorporating feedback, and ensuring that all regulatory requirements are met. BDD can support regulatory engagement through the medium of Scientific Advisory Meetings. Helping you steer your project in the right direction.

Track Record of Compliance: Our team has extensive experience navigating the regulatory landscape, with a proven track record of compliance. This experience enables us to anticipate regulatory challenges and address them effectively, ensuring that our trials proceed smoothly and efficiently.

Specific Actions and Achievements:

Regulatory Approvals: We have successfully obtained approvals for hundreds of trials over 2 decades. Our detailed submissions and thorough preparations ensure that our protocols meet all necessary standards.
Safety and Quality Audits: Regular internal and external audits are conducted to ensure ongoing compliance with regulatory requirements. These audits help us maintain the highest standards of safety and quality in all our trials.
Training and Expertise: Our team is well-versed in the latest regulatory guidelines and industry best practices. Continuous training and development ensure that our staff remains knowledgeable and capable of meeting regulatory expectations.

Expertise – Our FIH PI

As a key member of the BDD team, Dr. Pui Man Leung, with his appointment in April 2023, brings a wealth of experience and expertise to the forefront of pharmaceutical medicine.

Dr. Leung’s career, beginning with an MBChB from Aberdeen Medical School in 1989, has been marked by key roles in clinical research. His expertise was further recognized with a Diploma in Pharmaceutical Medicine in 2008 and entry onto the Specialist Register for Pharmaceutical Medicine in 2010. Prior to joining BDD Pharma, he was the Senior Director of Early Phase Research at MAC Clinical Research, leading significant advancements in early drug development.

At BDD, Dr. Leung’s focus is on leading first-in-human clinical trials and early-stage drug development. His extensive experience in various therapeutic areas is invaluable in driving innovative research strategies. Dr. Leung’s embrace of AI in drug development is set to revolutionize BDD Pharma’s approach to pharmaceutical research.

Dr. Leung’s vision for integrating AI and digital health technologies is pivotal for BDD Pharma’s future endeavours in pharmaceutical medicine. His leadership and strategic insights are crucial in navigating the complex landscape of drug development and clinical trials.

Dr. Pui Man Leung’s addition to the BDD team represents a significant step forward in our pursuit of innovation in pharmaceutical medicine. His expertise and forward-thinking approach are integral to the development of novel therapies and advancements in the field.

Advanced Technologies

At BDD, we leverage cutting-edge technologies to enhance the quality and reliability of our First in Human (FIH) trial data. Our advanced technological capabilities ensure precise and accurate results, providing robust support for drug development.

Gamma Scintigraphy: Our use of gamma scintigraphy allows us to visualise and quantify the behaviour of pharmaceuticals in vivo. This advanced imaging technique is instrumental in tracking the distribution and localisation of drugs within the body, providing critical insights into their efficacy and safety. Gamma scintigraphy helps in understanding drug absorption, distribution, metabolism, and excretion, which are vital parameters in early-phase clinical trials learn more.

Case Studies

Our track record of successful trials is exemplified through detailed case studies. These case studies highlight the challenges faced, the innovative solutions implemented, and the successful outcomes achieved, demonstrating our expertise and building credibility. Learn more

Ask our Experts

World Class Drug Delivery Company

Clinical site

Glasgow Royal Infirmary
84 Castle St
Glasgow
G4 0SF, UK

+44 (0)141 552 8791

Formulation site

Bio-City Scotland
Bo’ness Road
Chapelhall, Newhouse
ML1 5UH, UK

+44 (0)141 404 9540

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