Micah Rimer
President and CEO
Micah leads VCS, bringing technology and operations leadership from pharmaceutical R&D at Bayer, Novartis and GSK.
Micah is a UC Davis computer science graduate, and built scalable vaccine tech platforms through two pandemics and spearheaded digital transformations at Bayer, Novartis, and GSK. Leading global teams across the US and Europe, he empowers R&D to deliver results faster by eliminating operational bottlenecks. He’s driven high-stakes programs—from M&A and divestments to major reorganizations—uniting diverse, multicultural teams around bold change agendas. Passionate about cutting non-value work, Micah now brings his proven track record of streamlined tech to deliver innovative solutions.
Nathaniel Katz
Chief Scientific Officer
Nat brings decades of work in clinical trial methodology, statistics and pain research, the disciplines behind trial reliability.
Nat is a neurologist and pain management specialist with over 25 years of experience in clinical trials, including running a clinical research center at Brigham and Women’s Hospital in Boston. He has an advanced degree in statistics from Columbia and was Chairman of the Advisory Committee to the pain division of the FDA.
For the last 20 years, he has been a leading researcher on the impact of study conduct and measurement error on trial outcomes, in concert with FDA public-private partnerships such as IMMPACT. At Analgesic Solutions, the first company he founded, he led the development, validation, and commercialization of a suite of tools to reduce measurement error in clinical trials, including central statistical monitoring, which led to its acquisition in 2019. VCS represents a continuation of that work with ever more sophisticated tools.
Dr. Katz has over 200 publications in the fields of pain, development of analgesics, and clinical research methodology. See his publications on measurement error in clinical trials.
Heike Reinstaedtler
Senior QA Advisor
Heike brings the clinical quality, audit and inspection experience a TMF review depends on, including audit methods for sites, vendors, systems and TMFs.
Heike is an independent senior quality consultant supporting small biotech and start-ups in the area of clinical development quality. She has more than 30 years’ experience in the biotech industry focusing on quality in clinical R&D and drug development. Heike has built and developed quality teams and successfully led global teams through transformation and reorganization in different major companies including Novartis and GSK. She brings wide-ranging knowledge and deep understanding of Good Clinical Practice, Quality Management Systems, their operations and related technical solutions and developed methodology for audits of clinical trial sites, vendors and systems, including Trial Master Files. During her career, Heike has managed various inspections in the clinical and pharmacovigilance area working with inspectors from different health authorities including EMA, FDA and PMDA.
Amit Nayak
Technical Lead and Security Manager
Amit brings regulated IT, GxP compliance and data governance experience to our technology and to how we protect client data.
Amit is a senior program and product management professional with more than 25 years of experience in life sciences, regulated IT and global service delivery, including 16 years in the Benelux region working with GSK and Novartis. Having governed large programs spanning M&A and divestment transitions, data governance, GxP compliance and service delivery, he has built a reputation for bringing structure and delivery discipline to complex, high-stakes environments. Amit has led global teams across multiple geographies and consistently driven measurable improvements in operational performance and regulatory compliance. He holds ITIL, PRINCE2 and ScrumMaster certifications.
Rashmi Kulkarni
Independent GCP QA Auditor and Consultant
Rashmi brings hands-on GCP audit experience across investigator sites, CROs, vendors and TMF audits to VCS’s AI-assisted TMF reviews.
Rashmi is an independent GCP QA auditor and ISO 9001-trained Lead Auditor with more than two decades of experience in the pharmaceutical industry and clinical quality assurance. She provides end-to-end GCP audit support across investigator sites, CRO operations and clinical trial vendors, using a practical, risk-based approach. Her experience includes investigator site audits, full-service CRO qualification audits, functional vendor audits, TMF audits, and inspection readiness and support during inspections. She has conducted audits on-site and remotely across Asia, Europe and North America. Rashmi supports Vital Clinical Solutions’ AI-assisted TMF reviews, applying independent QA judgment to assess potential issues and determine findings.
Bari Rascoe
Data Protection Officer
Polsinelli PC, external counsel to Vital Clinical Solutions
Bari is an attorney at Polsinelli PC, external counsel to Vital Clinical Solutions. Through that engagement, she serves as our designated Data Protection Officer, providing independent privacy oversight as an outside advisor.
Read Bari’s bio at Polsinelli
