Interventional Studies

Advancing Peri- and Post-Approval Research

Evidera’s interventional study team has extensive experience in designing global, regional and single country studies in the peri-  and post-approval space, including traditional IIIb/IV studies as well as Extended Access/Open Label Extension, Expanded Access/Compassionate Use, Lactation/Placental Transfer, and Regulatory Post Marketing Commitment Surveillance Studies. This research generates impactful medical data through structured studies that build a larger body of evidence around a product or specific patient population to better inform appropriate clinical practice, enable optimal commercialization and market access, and address specific post-approval health authority requirements. All of our studies are conducted following Good Clinical Practice (GCP) and research principles, but do not require the same level of monitoring or lab collection since the research often follows the standard of care.

Evidera has developed global process standards and tactics for medical affairs research that allow us to develop streamlined and cost-efficient programs that maximize data collection, monitoring and quality while minimizing operational risk. Our focus is on relaxing inclusion and exclusion criteria to mimic the normal clinical practice of the specific patient population, as opposed to the more highly-restricted populations that are required to move a product through development and on to registration.

Our team has deep country-level knowledge of ethical and regulatory requirements, patient privacy legislation, investigator grant policies, academic and site networks, patient associations, national health databases and local healthcare systems. At the outset of protocol planning, we leverage a blend of resources to gain local intelligence to customize each project for successful execution.

Excellence in Study Design and Execution

  • Extensive experience – dedicated operations, regulatory and global clinical supply teams with experience across ~116,000 patients and ~15,000 sites globally in the past 5 years
  • Specialist medical affairs team – significantly beat industry benchmarks in study start-up and patient recruitment time when working under an early engagement partnership model
  • Therapeutic area experts – capabilities across a wide range of indications, and ability to leverage PPD’s network of clinicians and global operations professionals
  • Integrated partnership model – flexible and proactive operating and governance model customized to unique needs
  • Innovation through technology and collaborations – collaboration with Healthcore; able to work directly with Acurian and Synexus for patient enrollment and site management; multiple options for electronic data capture (EDC) mHealth and eConsent solutions; partner with multiple vendors for ‘bring your own device’ (BYOD) technology

We Can Help You:

  • Generate data to address peri- and post-approval evidence gaps
  • Meet Health Authority requirements for post marketing safety surveillance
  • Optimize data flow to answer key asset/brand questions in a timely manner
  • Inform appropriate clinical practice and product use, and ensure data are available to answer medical communication queries
  • Enable optimal commercialization and market access
  • Validate new dosing or models of administration
  • Enhance exploratory analyses through innovative collaborations with scientific experts

Interventional Study Offerings

  • Phase IIIb/IV studies
  • Expanded access / compassionate use programs (EAP/CUP)
  • Extended access programs (XAP) / Open label extension
  • Post-marketing commitments
  • Lactation/Placental Transfer studies
  • Pragmatic/adaptive trials
  • Investigator-sponsored/initiated trials (IST/IIT)

Experts

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