In the complex world of pharmaceutical and biotechnology drug development, PIVOTAL serves as your trusted medical partner – delivering expert medical oversight and strategic insight across every phase of your clinical trials. We empower your teams to navigate challenges, manage risks, and accelerate the delivery of innovative therapies to patients worldwide.
Comprehensive Medical Solutions for Every Stage of the Clinical Development life-cycle
Dedicated Medical Monitoring & Safety Oversight:
- 24/7 Medical Support for urgent queries and critical safety events.
- Thorough assessment of Adverse Events (AEs) & Serious Adverse Events (SAEs), including causality assessment and accurate medical coding.
- Proactive evaluation of Eligibility Criteria & Protocol Compliance to ensure study integrity.
- In-depth Medical Data Review & Trend Analysis for early detection of safety signals.
- Expert Medical Support for investigators, including Training and Educational initiatives.
Strategic Medical Consultation & Drug Development Planning:
- Collaborative Protocol Development & Medical Review, to ensure scientific rigor and regulatory alignment.
- Strategic input on Clinical Development Plans, to optimize study design and patients´ population targeting and selection.
- Expert Medical Support for Regulatory & Competent Authorities´ Interactions, including preparation of submissions and responses.
- Development of Robust Safety Management Plans to proactively identify, assess and mitigate risks.
- Preparation and facilitation of Advisory Committee Meetings, to ensure alignment and impactful presentation of medical strategy.
- Facilitation of engagement between Pharma/Biotechs Sponsors and Cooperative Research Groups to enhance collaboration and trial efficiency.
Expert Medical Review for Documentation & Reporting:
- Medical Input for Independent Data Monitoring Committee (iDMC) & Steering Committee deliberations to support informed decision-making.
- Medically accurate Clinical Study Reports (CSRs) in accordance with ICH guidelines.
- Clear and precise Medical Narratives & Summary Documents for comprehensive and compliant safety reporting.
- Support for the development of Medical Content for Scientific Publications & Professional Presentations.
PIVOTAL´s Advantage: Unparalleled Physician Expertise
–> Experienced Clinical Practitioners: PIVOTAL´s medical team consists of board-certified physicians across key specialities – including Oncology, Hematology, Neurology, Cardiology, Clinical Immunology, Internal Medicine, Public Health and others. With extensive hands-on clinical experience in direct patient care, our physicians bring practical understanding of disease management, diagnostic challenges and complexities, and the clinical implication of drug development. This deep clinical insight enables nuanced medical monitoring, agile problem-solving, and highly effective communication with investigators and study sites. At PIVOTAL we bring, to every clinical program, a firsthand understanding of the patient journey.
–> Deep Therapeutic Specialization:
- PIVOTAL´s medical team possesses a strong foundational knowledge of systemic diseases and their widespread impact – an essential assess for thorough medical monitoring across diverse therapeutic areas and indications, particularly in patients with comorbid conditions.
- Our dedicated oncologists and hematologists offer deep insight and understanding of cancer biology and the evolving landscape of treatment modalities. Their expertise spans both benign and malignant hematologic conditions and is especially valuable in trials involving advanced therapies such as cellular and gene therapies, targeted treatments and immunotherapies. This specialized knowledge enables precise safety assessments, accurate interpretation of efficacy endpoints, and strategic medical guidance critical in a field where highly specific medical oversight is essential.
Partner with PIVOTAL for Accelerated & Safer Clinical Outcomes
Unlock the full potential of your clinical development plans with PIVOTAL´s specialized medical services and physician-led expertise. Our medical team is ready to deliver strategic insights, enhance patient safety, and drive innovation across every phase of your trials.
MEDIA CONTACT
Ms. Natalia Farr
