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 PI for your study.

Providing clinical trial excellence for over two decades

BDD’s Comprehensive Offerings

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: Leveraging expertise to increase the likelihood of success.

Rigorous Safety Measures: Implementing strict protocols to protect trial participants.

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


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.