Medical Affairs & Monitoring

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Ensuring Oversight for Study Insight

Excelya ensures quality oversight of your trial at every step. Our services include medical writing, medical monitoring, risk and strategic planning, and safety oversight. We provide a full range of medical services for scientific communications and medico-marketing material, including regulatory submissions, across diverse therapeutic areas. We are committed to delivering high-quality documents, on time and on budget. These services can be offered on a stand-alone basis or as an integrated part of a clinical development program or study.

Safety, accuracy, integrity

Expert staff, inside and outside

Our Medical Affairs team works closely with local and international Key Opinion Leaders and with our pivotal operational departments, such as Clinical Operations for both Late Phase studies and Early Phase interventional trials, Regulatory Affairs, Data Management and Pharmacovigilance to deliver accurate and effective documents that meet the highest standards. Our highly flexible and customer-centric approach ensures constant communication with our clients to make sure your trial is done right.

Our Services

Medical Writing

  • Study design (all phases, including Adaptive design)
  • Protocol and Amendment
  • Case Report Form (CRF)
  • Informed Consent Form (ICF)
  • Paediatric Assent Form
  • Clinical Study Report (CSR)
  • Patient Safety Narratives
  • Investigator’s Brochure (IB)
  • Patient Information Leaflet
  • Educational Material for patients, healthcare professionals, and pharmaceutical company personnel
  • Patient Support Program design and supervision
  • Early Access Program consulting (NPP and Cohort)
  • Biowaiver Application document
  • Expert Report
  • Added Value Dossier
  • Scientific Article, Poster, and Presentation
  • Toxicology and Permitted Daily Exposure (PDE) report
  • Clinical Evaluation (CER) and Trend Report for medical devices
  • Readability Study
  • Usability Study
  • Time and Motion Study

Medical Monitoring

  • Medical review/advisory on study aspects and conduct
  • Medical assessment of Adverse Event reports for Pharmacovigilance
  • Medical review of Development Safety Update Report (DSUR) and Periodic Safety Update Report (PSUR)
  • Medical input to the development and review of Risk Management Plan (RMP) and Signal Management
  • Benefit-risk assessment of medicinal products and devices

Feasibility

  • Protocol review and guidance
  • Contact with key opinion leaders requiring study specifications
  • Provision of epidemiological and scientific data
  • Feasibility questionnaire/survey development and review

Training

  • Medical Advisor course
  • Study design and conduct
  • Study document overview

Medical Support

  • Client-tailored advisory, review, and design of scientific documents, queries, and activities
  • Literature review
  • Functional Service Provision of Medical personnel

Market research and strategic planning

  • Therapeutic area questionnaires
  • Content of discussion of Focus Groups & Advisory Boards
  • Collaboration with Sponsor’s Medical and Market Development departments
  • Medical web/mobile application design