Medical Affairs

With extensive research experience and practical clinical knowledge, our medical affairs teams bring a comprehensive safety dimension to your research. We’re solutions-orientated, hard-wired to always find the very best approach.

Expertise

Our medical monitors have formidable experience in cardiology, oncology, neurology, immunology, endocrinology and orphan indications. From conception of clinical development plans to approval – and beyond – we provide medical oversight that ensures patient safety, ethical conduct and regulatory compliance.

In the past 5 years, our medical monitors have managed global safety studies of more than 3000 patients.

We also work with a pharmacovigilance partner to deliver an integrated safety approach.

Global but local

Being local means we have an in-depth understanding of specific regional regulatory requirements and any cultural sensitivities. We have medical affairs teams in more than 40 countries monitoring and safety reporting 24/7.

Integral approach

  • Centre – Medical Affairs
  • Clinical Development Team
  • Clinical Operations
  • Medical Writing
  • Pharmacovigilance
  • Regulatory Affairs
  • Data Management

Medical Affairs Services

  • Clinical Development
  • Literature Evaluation
  • Market Research
  • Registration Strategies
  • Gap Analysis
  • Input to Clinical Development Plans (CDPs)
  • Inputs to Protocols
  • Feasibility Assessment
  • Investigator Interactions

Study Start-up

  • Document Review
  • Product Specific Training
  • Therapeutic Area Training
  • Investigator Site Support
  • Operations Support
  • Setting up Data and Safety Monitoring Board (DSMB) and Clinical Endpoint Committee (CEC)
  • Safety Plan Development

Study Ongoing

  • Enrolment Support
  • Handling Investigator Query
  • Emergency Unblinding
  • Safety and Efficency Data Review
  • 24/7 Serious Adverse Event (SAE) Management
  • Medical Coding Review
  • Data and Safety Monitoring Board (DSMB) and Clinical Endpoint Committee (CEC) interactions
  • Periodic Safety Update Report (PSUR) Development

Post Study

  • Regulatory Interactions
  • Marketing Authorization Application
  • New Drug Application
  • Orphan Drug Application
  • Pediatric Investigation Plans
  • Risk Evaluation & Mitigation (REM) Strategy and Risk Management Plans (RMPs)
  • Publication Planning

Examples of Projects Completed

Early-phase study in chronic kidney disease – 160 subjects
Monitoring activity involved 24/7 safety reporting, eligibility screening, randomization and weekly dose titration for a duration of one year. We managed more than 100 SAEs with multiple follow-up reports along with screening, randomization and dose titration with no errors during the entire study duration.

Late-phase clinical trial – 1066 diabetic patients
We centrally managed 24/7 safety reporting of 43 centres across 6 countries to ensure no reports were delayed or omitted. This study took place over a 6-month period across multiple time zones.

Early-phase program in dermatology
We provided medical monitoring covering photographic assessments, lab reports and safety data review. Closely assessing safety and efficacy outcomes, we provided guidance to investigators for concluding the study with an excellent outcome.

Find out more about how we have invested in the best in class E-Clinical Technologies and our Project Management Office to provide you with leading quality services.

Get in touch to find out more about medical affairs.

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