Advanced Medical Monitoring Services for Clinical Trial Success

At Navitas, we understand the critical role medical monitoring plays in steering pharmaceutical and biotech companies towards successful clinical trials. Our advanced Medical Monitoring Services offer strategic oversight to ensure excellence throughout the trial process.

At Navitas, we prioritize client success by delivering tailored solutions that meet your specific needs. Our commitment to excellence, coupled with our extensive expertise and global reach, sets us apart as a trusted partner in clinical trial management. With a focus on streamlining processes, reducing costs, and optimizing trial outcomes, our medical monitoring projects empower you to bring life-changing therapies to market efficiently and effectively.

With over two decades of experience, our team of medical monitors/clinicians offers diverse knowledge to serve as an extension of your team or provide standalone engagements. From study start-up to post-study review, our medical monitoring clinical trial services ensure comprehensive medical oversight, powering possibilities towards successful clinical outcomes.

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Our Medical Monitoring services are extensive

Thought Leadership
Thought Leadership
Medical monitors drive protocol optimization through advanced biometrics and risk-based monitoring. They ensure regulatory compliance and ethical vigilance, with expertise in novel therapeutic modalities. Post-trial, they synthesize statistical outcomes and translational insights.
Planned Clinical Studies
Planned Clinical Studies
Comprehensive support across phases including study rationale, trial design, outcome measures (e.g., safety, efficacy, PK, PD, surrogate markers, patient-reported outcomes), key eligibility criteria, sample size, and study durations.
Post-Approval Clinical Trials
Post-Approval Clinical Trials
Post-Approval Clinical Trials: Phase IV trials for additional therapeutic indications, comparisons with competing therapies, new drug formulations, and special populations (e.g., paediatrics). Includes specific commitments to regulatory agencies as a condition for initial approval.
Proof-of-Concept Checkpoint
Proof-of-Concept Checkpoint
Early milestone decision to evaluate if the drug meets the TPP for further investment and research, involving detailed discussions with statisticians, project team members, and senior management.
Risk Assessment and Mitigation
Risk Assessment and Mitigation
Evaluation of significant risks and development of mitigation plans, ensuring compliance with regulatory requirements and integrating feedback from clinical teams to enhance trial integrity and success.

Brochure

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Efficient Clinical Trials: Real-Time Oversight & Insights

Navitas Life Sciences has In-depth domain expertise, vast experience in managing global studies, incorporated proven technologies, and more to manage efficient trials.

CASE STUDY

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Successful End-to-End Clinical Trial, Risk Management, Monitoring Support

Find out how we received Regulatory approval within 45 days, effectively monitored at site level, with successful completion of 2 FDA site audits without any 483 findings.

ARTICLE

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Key Takeaways From The FDA Guidance On DCTs

Published in: Life Science Leader
An overview of the guidance provided by USFDA on decentralized clinical trials

Extensive Experience in Managing Efficient Clinical Trials

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Phase I-IV Clinical Trials
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Therapeutic Areas
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Years of Experience
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Regulatory compliance

Gain the Navitas Life Sciences Edge

Holistic Approach

Holistic Approach

Balancing scientific rigor with cost-effectiveness.
8 Offices World Wide

8 Offices World Wide

Including 4 delivery centers across the globe.

Specialized Focus

Specialized Focus

Expertise in vulnerable populations and niche areas.
Strategic Support

Strategic Support

From TPP to regulatory compliance, we cover all bases.
Expert Team

Expert Team

Medical monitors with rich academic and industry experience.

BLOGS

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FAQ on Medical Monitoring Services

Our Medical Monitors have vast therapeutic knowledge and clinical research experience to provide strategic and specific support throughout the clinical trial.
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Among Top CROs in 2024: Navitas Life Sciences drives Efficient Clinical Trials

Clinical trials are essential for bringing new treatments to market, which CROs support by providing comprehensive planning, execution, and management services.
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Advancing Patient-Centric Clinical Trials with Navitas Life Sciences

Patient-centric clinical trials, which are efficient, productive, and engage with patients and their needs, are at the forefront of Navitas Life Sciences' approach.

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