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Regulatory Affairs
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Pharmacovigilance
Pharmacovigilance
Integrated Safety Management from Development to Market
Delivering end-to-end pharmacovigilance services to ensure the highest standards of drug safety and regulatory compliance globally.
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Excellence in Pharmacovigilance & Regulatory Affairs
Superior quality pharmacovigilance and regulatory affairs services helping the pharmaceutical industry make safe and effective healthcare products available worldwide.

Medical Monitoring Services

We offer medical monitoring services, providing 24/7/365 medical support to clinical trial Sponsors, investigational sites, and study teams.
Our Services
Our services include strategic consultancy during study design and continuous clinical and medical oversight throughout all phases of a clinical program.
  • Development of Medical Monitoring Plans
  • 24/7 coverage medical monitoring
  • Acting as the medical point of contact for Investigators and sites
  • Continuous medical support on eligibility, issues or concerns
  • Review of laboratory findings
  • Serious Adverse Events (SAEs) and safety information review
  • Causality assessment discussions
  • Medical coding of AEs and medications (MedDRA, WHO Drug Dictionary)
  • Medical review of study documents and materials (protocols, CRF, data, listings, reports)
  • Medical consultations
Insuvia pharmacovigilance and regulatory services
Facts & Figures
The Numbers Behind Our Success
  • 30+ Clinical trials overseen
  • 20+ Medical monitoring plans written
  • 365d. 24/7 safety and medical monitoring
FAQ’s
Can't find your question? Contact us, we're here to help!
  • What are the qualifications of your Medical Monitors?

    Our medical monitors hold advanced medical degrees, such as PhDs in Clinical Pharmacology, and have substantial experience in clinical practice. Many have acted as clinical study investigators and/or clinical trial monitors/associates, providing them with in-depth knowledge of trial operations and patient care. Their expertise includes interpreting and assessing clinical data, ensuring compliance with GCP guidelines, and overseeing the safety and integrity of clinical trials. This hands-on experience makes them highly effective in managing and monitoring clinical studies.

  • Can you work based on our Medical Monitoring Plan?

    Yes, we are flexible and can either develop a medical monitoring plan tailored to your study or work within your existing setup. Whether you prefer to use your established procedures or need us to create a new plan, we can adapt to meet your specific needs and ensure effective monitoring throughout your clinical trial.

  • Can you assure 24/7 Medical Monitoring?

    Yes, we can provide 24/7 medical monitoring. We can set up study-dedicated communication lines, including phone, email, and fax if needed. We can also deploy medical monitors across multiple time zones to ensure continuous coverage and immediate response at any time, supporting the safety and integrity of your clinical trial around the clock.

Can't find your question? Contact us, we're here to help!
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