Medical monitoring for the entire clinical trial

We offer ongoing medical monitoring to ensure timely detection of any medically relevant issues. Medical monitoring is individually tailored to your requirements.

The medical monitor will serve as the medical expert for assigned clinical trials. He will provide input into the design and conduct of clinical trials, assessment and interpretation of safety data, and contribute to investigator training.

Our medical monitors offer clinical trial oversight, strategic consulting and safety support

Work with high-skilled experts

Our medical monitors are professional Medical Doctors with several years of experience in pharmaceutical medical positions.

ExperTrials is comprised of Clinical Research Consultants from around the world who are experienced in all aspects of clinical trial execution from feasibility assessments to study closeout and all steps in between.

They are able to apply their practical knowledge and experience to present solutions for the issues that occur in clinical research studies. Our medical monitors have also expertise in different therapeutical areas.
At ExperTrials, we have gained a depth of knowledge which has allowed us to apply new insights and innovative science to clinical trials.

The team responsibilities include detailed clinical study protocol review of inclusion/exclusion criteria, medication administration, lab tests and safety and review of Clinical Study Report and manuscript.

Our experienced monitors ensure the quality and compliance of your clinical trial.

Regular training to the project management and CRA team generate confidence in the field. Our medical monitoring team helps the project stay on track and deliver quality data.Our focus is on the solutions, and our primary concern at ExperTrials is the patient.

Our vision of a strategic partnership is built on open communication and shared expectations that allow us to customize our solution to your specific needs.

Our medical monitors offer the following clinical trial oversight, strategic consulting and safety support including :

  • Providing medical review and input into key study documents, such as protocols, case report forms, clinical study reports, data analyses, and regulatory submissions
  • Reviewing all Serious Adverse Events (SAEs) and safety information
  • Recommending Key Opinion Leader (KOL) and Advisory Panel Networks
  • Providing representation at regulatory meetings
  • Reports, data analyses, and regulatory submissions
  • Final reconciliation of medical data
 

Our medical monitors offer the following clinical trial oversight, strategic consulting and safety support

Do you need some additional information concerning Medical monitoring ? Get in touch with us

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Generic Application

As for all medicines, generic medicines must obtain a MA before they can be marketed.

The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). A generic medicine is developed to be the same as a medicine that has already been authorized, called the reference medicine.

As FDA and EMA recommendations are to provide new methods to identify and eliminate unnecessary in vivo BE studies.

“WHO’s guidance” gives the following definition for biowaiver: « The term biowaiver is applied to a regulatory drug approval process when the dossier (application) is approved based on evidence of equivalence other than in vivo bioequivalence test. » In other words, biowaiver means an exemption for time consuming and expensive in vivo bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution.

By applying biowaiver approaches whenever possible, generic companies can save a lot of resources.

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