Comprehensive Medical
Monitoring Services

Strategic Oversight for Clinical Trial Excellence

MEDICAL MONITORS AS THOUGHT LEADERS FOR DRUG DEVELOPMENT: ROAD MAP TO SUCCESS

Pharma industry is at inflection point wherein successful product authorization is required in a cost effective and timely manner without compromise on scientific validity. Medical Monitors role in helping pharma achieve this is undeniable, yet many before have struggled to harness complete expertise of the medical lead. At Navitas, we ensure that the involvement of medical lead is much more deeper:

  • Holistic approach with customer-focused mindset: Scientific guidance in alignment with regulatory prerequisites, and cost effectiveness.
  • Support in overall drug development strategy including the target product profile (TPP), regulatory, nonclinical, and clinical development plans.
  • Sharp academic footing, and rich experience in both industry and healthcare systems
  • Subject Matter Experts (SMEs) for all major therapeutic areas
  • Strategic KOL Engagement
  • Global medical monitoring experience (North America, EU, and Asia Pacific)
  • Familiar with finer nuances of major regulatory authorities (USFDA, EMA, MHRA, CDSCO, TGA, SFDA etc.)
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Comprehensive Involvement of MM in Overall Clinical Development Program:

Pharma industry is at inflection point wherein successful product authorization is required in a cost effective and timely manner without compromise on scientific validity. Medical Monitors role in helping pharma achieve this is undeniable, yet many before have struggled to harness complete expertise of the medical lead. At Navitas, we ensure that the involvement of medical lead is much more deeper:

Summary of all planned clinical studies, from Phase I through Phase III, including the study rationale, trial design, outcome measures (e.g., for safety, efficacy, PK, PD, surrogate markers, patient-reported outcomes, etc.), key eligibility criteria, sample size and study durations.

Post-approval clinical trials:

  • Phase IV trials for additional therapeutic indications, comparison with competing therapies, new drug formulations, and special populations (e.g. pediatrics).
  • Specific commitments made to regulatory agencies as a condition for initial approval.

“Proof-of-Concept” checkpoint: An early milestone decision to decide if the drug can meet the TPP for continued investment and research. This will entail detailed discussion with statisticians and other project team members, as well as senior company management.

Assessment of any significant risk and the mitigation plans.

With over 20 years of experience, our team of clinicians provide a wealth of diverse knowledge that can provide insights as stand-alone engagements or serve as an ongoing extension of your team.

Navitas Life Sciences

is named as a Major Contender
in Everest Group’s

Clinical Development Platforms Products
PEAK Matrix® Assessment 2022

Best-in-class Medical Engagement from Design to Close Out

Our Medical Monitoring services at Navitas start before the study starts and is done in well-structured way outlined in the study specific medical monitoring plan (MMP).

Study Start up

  • Reviews critical study documents like Protocols, IBs, CRF, Statistical Analysis Plan (SAP), and Data and Safety Monitoring Board (DSMB) charter.
  • Trains research personnel at sites as well as project team in the therapeutic area, study indication, protocol, and safety reporting issues.
  • Regulatory support (Pre-IND, IND, SEC etc) SEC)

During the Study

  • Continuous guidance to the sites and the study team for scientific issues and safety questions
  • Real time advice on study eligibility
  • Review of Line listings (LL) related to safety parameters like Medical History, Concomitant Medications, AE/ SAE/ AESI, Lab data, ECG, Radiological Scans etc), Vitals, Physical Examination
  • Review of LL related to efficacy parameters
  • Review of Protocol deviations
  • Trend analysis of critical safety and efficacy data
  • Screen Failure / Withdrawals analysis
  • On site Medical Monitoring visits for critical issues

Post study

  • Reviews data management coding for consistency
  • Reviews tables, Listings and Figures (TLFs)
  • Reviews the Clinical Study Report (CSR)
  • Provides recommendations for future studies/development

Strategic trial oversight with an expansive and granular view of clinical trials, from I-IV stages, will instill certified medical expertise into your trials, improving clarity and coherence about patient safety. Conduct your clinical trials against the backdrop of enhanced safety assessment to change the future of medicine with your life changing drug products.

Medical Monitoring Case Study

Our Medical Monitoring Services Provide Enhanced Safety Assessment

Learn how we supported a US Based mid-size biotech company with end to end development of their first in class therapy for critically ill covid patients.