Ajinkya Sakpal

Clinical research professional with 3 years of experience optimising clinical trial operation including Clinical trial regulatory filing for MHRA, DGCI, FDA, with execution of Risk based monitoring to ensure data integrity, embedding these key risk indicators in SOPs and developing high impact patient recruitment strategies for seamless trials.

Clinical Trial Consultant at Acesso Innovation lab (2023-01 – Present)

• Consulted on and executed over 25+ clinical trial regulatory filings for major global health authorities, including the MHRA, FDA, and DGCI, ensuring strict adherence to evolving statutory guidelines.
• Embeded a Risk-based monitoring framework in SOPs to proactively mitigate operational risks, ensuring clinical data integrity and safeguarding patient safety.
• Provided advisory on trial protocols, mitigating risks by analyzing multiple scientific data and resources according to regions.
• Managed complex projects by implementing patient recruitment strategies and conflicting priorities and driving project to meet the trial timeline with safety.

Research Associate at Swid Process Technologies (2020-01 – 2021-01)

• Spearheaded the development and testing of UVC-based COVID-19 sterilization products, ensuring all processes strictly adhered to FDA guidelines and regulatory protocols.
• Directed root-cause analysis initiatives to overcome complex technical challenges in sterilization processes, guiding the team toward effective and compliant solutions.
• Translated complex technical observations into clear, actionable reports, ensuring strategic alignment and seamless communication across diverse

Industrial Trainee at Serum Institute of India (2020-01 – 2020-12)

• Conducted rigorous in-process and finished product QC testing across major vaccine groups (MMR, DTP, Hep-B) to ensure strict quality adherence.
• Demonstrated strong proficiency in data integrity and accurate record-keeping by strictly executing established Standard Operating Procedures (SOPs).
• Maintained thorough documentation systems, aligning hands-on quality control activities with Good Clinical Practice (GCP) guidelines and regulatory compliance.

MSc in Clinical Drug Development – Queen Mary University of London (2021-01 – 2023-12)

BSc in Biotechnology – Bharti Vidyapeeth University (2018-01 – 2021-12)