Medical Affairs and Clinical Research
The importance of communicating early decisions and productivity
Medical affairs or the investment of resources, time, and funding grows with successive stages, from pre-clinical through phase 3. Thus, the cost of a failed phase 3 trial is not just the cost associated with the trial itself but the cost of all prior trials and the cost of lost time pursuing a potentially viable alternative.
Maintaining medical affairs and a philosophy of continual improvement in early clinical development concerning clinical trials and optimizing every aspect of the research and development process is essential.
- Improve protocol development, including current trends in clinical trial designs and endpoints.
- Benchmark relevant historical trial enrolment with unmet needs and ongoing trial inclusion criteria.
- Develop a clinical strategy including patient segmentation and biomarkers, streamlining operational costs through more efficient trials.
- Gain in-depth insight into patients’ unmet needs, concerns, and time investment.
Our experts support and inform clinical trial strategy, design, and management with crucial protocol details, such as study objectives, endpoints, and inclusion/exclusion criteria. We also monitor trials providing insights into trial timing, enrollment successes and failures, patient segments, trial outcomes, biomarker tags, and study data quality.
We value:
- Patient time investment
- Employing quantitative measures
- Considering the patient’s financial burden
- Evaluating poor recruitment, dropouts, and underpowered trials
- Additional costs associated with recruitment
- Respecting the patient’s concerns
- Patient recruitment
- Eligibility criteria
- Financial impact
Medical Affairs Areas of Expertise
Clinical Plan & Study Design
An early strategy ensures efficiency in clinical development and helps build the first step of a successful study.Â
Clinical Research Consulting
BBCR embraces innovative consulting strategies for effective clinical plans and product development.Â
Medical Monitor
Ensuring subject/patient safety and compliance with a clinical trial protocol’s requirements are paramount to any study’s success in meeting its intended objectives.
Phase 1 & 2 Studies
Phase 1 & 2 studies can individually collect data on early safety, dose selection, and effectiveness trends. Combining the phase 1 & 2 study objectives in one phase 1/2 study maximize data-gathering to answer specific questions.
POM & POC
Designing the Proof of Concept (PoC) and Proof of Mechanism (PoM) studies with the clinical plan and regulatory strategy in mindÂ
Biosimilars
The orphan class of biologicals deserves special attention for biosimilar development as they provide necessary treatment to the patient.
Medical Device
BBCR’s clinical research experience can help accelerate your medical device approval by anticipating challenges, managing risk, and consulting with you early before FDA meetings, co-owner issues and trials.
Let’s Work Together
BBCR is committed to meeting the challenges of sponsors and investors seeking a clear path to market.
We invite you to reach out today to learn more.