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
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:
At BDD we understand that one of the key challenges for any clinical trial is the recruitment of eligible participants. Having access to a diverse and engaged pool of volunteers will smooth the progress of your research ensuring rapid progression of your trial.
With our extensive experience and proven record of accomplishment spanning two decades, our healthy volunteer and patient recruitment process will deliver your trials successful and efficiently.
Targeted Outreach: We employ a multi-faceted approach to reach potential participants. Our experienced team utilise various channels such as social media, online advertising, and targeted radio campaigns to connect with individuals who may be suitable for your study. Through strategic, AI driven messaging and captivating, on trend social content, we ensure maximum visibility and engagement.
Healthy Volunteer/Patient Databases: We maintain an extensive database of pre-screened participants who have expressed an interest in participating in clinical trials. Our database includes individuals from diverse demographics and geographic locations, ensuring a broad range of potential healthy volunteers for your trial. We also work closely with the NHS and partner CRO CPS Research to access an array of patient groups.
Streamlined Screening and Enrolment: Our rigorous screening process ensures that only eligible and motivated participants are enrolled in your trial. We handle the necessary paperwork, consent forms, and regulatory compliance efficiently, reducing administrative burdens for both you and the participants.
Volunteer Education and Support: We prioritize the well-being of our participants and ensure they are fully informed about the trial process. Our dedicated team provide comprehensive education materials, conduct one-on-one consultations and offer ongoing support throughout each trial. By addressing any concerns or queries, we create a supportive environment that enhances the volunteer’s overall experience, meaning they come back again, giving us a pool of reliable participants.
This was my third time to work with BDD as a volunteer subject for a clinical trial. BDD is lucky to have a great team of staff who always look after me every step of the way during the trial period. They go out of their way to keep in touch and make sure that I am as comfortable and well as possible during the study. Spending the day at the centre can be long, but the staff are always engaging and willing to talk, they make the trial feel like a team effort.
By partnering with BDD, you can be confident that your trial’s data management and statistical needs are in good hands. Our commitment to accuracy and reliability ensures that the data collected in your trial is of the highest quality and can withstand rigorous scrutiny.
Data Collection and Standardisation: We provide a bespoke service offering a variety of electronic data capture (EDC) solutions, such as Castor and Viedoc or paper based data management dependent on your needs. We can also use Medrio & Veeva based on your recuirements.
Data Validation and Cleaning: Data integrity is paramount in clinical research. Our team perform thorough data cleaning, employing automated checks and manual reviews to identify and rectify inconsistencies, missing data, and outliers, ensuring that your data is accurate, reliable, and of the highest quality.
Data Security and Confidentiality: We understand the sensitive nature of clinical trial data and the importance of protecting patient privacy. We implement stringent security measures to safeguard your information from unauthorised access, loss, or tampering. Our systems adhere to all relevant data protection regulations, such as GDPR.
Database Design, Development and Maintenance: Our team of dedicated experts provide database set up and maintenance tailored to your specific study requirements. Our databases support real-time data monitoring, data cleaning, query management and facilitate accurate reporting and analysis.
Data Analysis and Reporting: Unlocking valuable insights from your clinical trial data is crucial for making informed decisions and driving scientific advancements. Our skilled data analysts and partner biostatisticians collaborate closely with researchers to develop analysis plans and design appropriate statistical models. Our team generates comprehensive reports, customized to meet the specific requirements of Sponsors, regulatory authorities, and ethics committees.
Quality Assurance: We are committed to maintaining the highest standards of quality in our clinical services. Our Quality Assurance team performs regular audits, ensuring compliance with regulatory guidelines and adherence to standard operating procedures (SOPs). We strive for excellence in every aspect of our data management processes to ensure reliable and accurate data for your clinical trials.
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.
“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