For more than 20 years, BDD has worked with the smallest to the largest companies across the pharmaceutical, biotech and medical devices sectors providing a customised service that is appropriate for the phase and purpose of each clinical trial.
Accelerate your Phase I Trial by months with an integrated CRO + site
“With industry leading scientific expertise in clinical imaging and drug product design, BDD was an ideal partner for early stage clinical evaluation of complex drug products and implementation of new imaging approaches.” – Matt Burke – Senior Director, Head of Drug Delivery and CMC Leader
“We are happy to collaborate with BDD Pharma – their technology as well as integrated setup for early exploratory clinical testing is a great match for us and allow us to advance our Parkinson´s disease program towards patients.” – Anders Brandt Elvang – Chief Business Officer
We understand that a strong trial design is the cornerstone of a successful clinical study. Careful planning and a well thought out clinical strategy saves both time and budget. We have expertise in designing trials for pharmaceutical products, microbiome, nutraceuticals and devices.
We always ensure that our studies are appropriate for the development stage of the product, a good trial is elegant and robust, yet not over engineered. Our proactive, flexible designs allow you to respond to different study outcomes, eliminating the time and cost of preparing further regulatory submissions. Our adaptive studies include combined SAD, MAD dose escalation designs and SWIFT.
At the outset of the project, we will hold initial consultation sessions where our team will work closely with you to understand fully the requirements of your study and to develop a clear clinical strategy.
Our experienced clinical researchers and medical experts collaborate closely with you to design Phase I study protocols that align with your goals and regulatory requirements. We tailor the study design to address specific endpoints, participant populations, and dosing regimens, ensuring the most efficient and informative trial. Our adaptive trial designs allow for seamless adjustments based on emerging data, maximising the chances of success.
BDD Pharma offer a responsive and flexible expert team of medical writers comprising scientists, pharmacists and physicians.
We have more than 20 years’ experience in preparing documents for Early Phase studies which meet Regulatory Authority and Research Ethics Committee requirements.
We offer the following services to our clients:
Traditionally, clinical trials involve collaboration between pharmaceutical companies, research sites and CROs. However, by merging the functions of investigative site and CRO, BDD offer our clients several key advantages which reduce time and costs:
Streamlined Processes: Our integrated services eliminate the need for separate contracts and coordination between multiple parties, making trial initiation and execution more efficient.
Communication and Collaboration: We assign a dedicated project manager as a single point of contact who will meet with you weekly throughout the lifecycle of your project. This provides greater clarity and control throughout the trial.
Comprehensive Expertise: Our unique structure enables us to bring together the combined expertise of our physicians, pharmacists, biopharmaceutical scientists, data experts and GMP specialists.
Enhanced Quality Control: The single management of site and CRO enables better oversight and standardisation of processes leading to improved data integrity and reliability.