Lean Isn’t Only for Ozempic® – Lean Clinical Development™
Lean Clinical Development™ is our streamlined approach to early pharmaceutical development that cuts out the “fat” (a.k.a. unnecessary steps) from the process. Instead of the traditional long and winding road, we offer a single-point solution from initial formulation design through rapid, small-scale Phase I trials. How do we do it? By integrating everything under one roof – intelligent formulation design, “just-in-time” manufacturing, and agile clinical trial execution – we eliminate delays and hand-offs. The result is Phase I clinical data in record time, giving your program a competitive edge. In other words, we make the journey from molecule to human trials as efficient as possible without impacting quality.
“BDD was able to think out of the box in approaching some unusual formulation challenges in our development program. We were able to work interactively with BDD to get our new drug formulation program off the ground.”
Who benefits from going lean? Everyone who needs to de-risk development, stretch their R&D budgets, and get decisive early data faster. Whether you’re a Development Director at a large company or leading a creative biotech startup, this approach is built for you. Instead of coordinating multiple vendors (formulators, manufacturers, CROs) and endless project management calls, you have one expert partner handling it all. Fewer moving parts, fewer delays.
Why BDD’s Lean Clinical Development™ model is different: 25+ years of experience in drug delivery have taught us where the typical development pathways stumble and stall. We’ve redesigned that pathway to be faster, cheaper, and less risky for our partners.
Here are a few key benefits of BDD’s Lean Clinical Development:
Faster Phase I Data:
By combining formulation, manufacturing, and testing, we accelerate your timeline. For example, our just-in-time manufacturing approach means no waiting on lengthy stability studies – we make only what you need, when you need it. That means you dose patients sooner and get critical readouts quicker. Expensive, hard-to-make drug? No problem, we only require the smallest amounts.
Integrated Coordination:
BDD’s team handles everything end-to-end – formulation development, GMP manufacturing, clinical protocol, and trial conduct. This tight coordination means no communication gaps or last-minute surprises. The same scientists who design your dosage form are working with the clinicians who run your trial, ensuring a seamless flow of knowledge. It’s like having a dedicated in-house development team, but one that comes fully assembled and highly experienced.
Lower Costs:
Streamlining the process isn’t just about speed – it saves money. We eliminate duplicate efforts, big “resets” at formulation and clinical stages and idle time, which cuts down on wasteful spend. With integrated development, design and trials, you avoid the cost of transferring projects between separate contractors. In short, you’re not paying for overhead and delays at every step.
De-risked Development:
Our lean approach builds quality and problem-solving into each stage. We address drug delivery challenges early (thanks to our expertise in areas like controlled release and gamma scintigraphic imaging) so there are fewer issues in clinic. Plus, with our industry-leading volunteer recruitment rates (over 80% screen-to-enrollment), your Phase I study starts on time with the right patients. Fewer delays and surprises mean a more predictable, de-risked path to approval.
In a nutshell, “lean” for BDD means doing more with less – more speed and insight with less waste and risk. It’s a development diet that every drug program can benefit from. By shaving months off early trials and cutting down inefficiencies, we help you reach decision points faster and move on to Phase II and beyond with confidence. This isn’t just theoretical: it’s a proven model that has delivered for hundreds of development programs, from innovative biotech spinouts to big pharma projects.
While Ozempic® might be the talk of the town for getting people lean, BDD’s Lean Clinical Development is getting drug development lean – trimming timelines, slashing costs, and accelerating the journey to patients. In an industry where every month counts and every budget dollar matters, a leaner clinical development process can be the difference between being first-to-market or falling behind.
Ready to put your clinical development on a lean diet? BDD’s team is here to streamline your next project and help accelerate your therapy from lab to launch. After all, lean isn’t only for Ozempic® – it’s the future of efficient drug development.
Upcoming Conferences – Meet BDD!
12th Annual Outsourcing in Clinical Trials UK & Ireland 2025
10 – 11 June 2025 – Hilton Park Lane, London, UK
BDD is sponsoring and exhibiting at this popular London-based event. Meet the team attending below
- Darren Quinn – Head of Buisness Development
- Carol Thomson – CEO
- Lyn Corry – Research Medical Director
Discovery & Development Europe 2025
23 – 24 June 2025 – Congress Center Basel, Basel, Switzerland
BDD is sponsoring and speaking at this Switzerland based event. Meet the team attending below
- Darren Quinn – Head of Buisness Development
- Carol Thomson – CEO
- Fiona MacDougall – Director of Biopharmaceutics
Why BDD?
Experienced Team
BDD has over 25 years of success conducting early-phase confirmatory clinical trials.
Founded and Led by Science
Established in 1999 by scientists, BDD has consistently placed great science at the forefront of everything we do.
Proven Reliability and Track Record
BDD has a superb track record of reliability, supporting clients from formulation through to the clinic, with hundreds of satisfied partners.
Faster
BDD’s Lean Clinical Development™ approach significantly accelerates traditional development pathways.
Industry-Leading Recruitment
For decades, BDD has built a robust and effective database of volunteers and patients, achieving an industry-leading 80.2% screening-to-enrolment rate. With BDD, your study starts on time.
