Clinical Science and Medical Affairs

Supporting you across every stage of development

Our experts share their knowledge and experience in your therapeutic area to optimize your clinical trials and offer oversight to support a timely and cost-efficient drug development process. Our global team of clinicians and research professionals support the strategy, design, operations and evaluation of clinical trials. In addition, we advise on study endpoints and feasibility and bring medical input into protocol development.

We also have the skills to train and share knowledge with your project teams to further support your innovations across all your therapeutic applications.

Equipped with insights enabled by our proprietary Clarity tool, we take ownership for monitoring patient safety on an ongoing basis to ensure the progress of your clinical trials, minimizing protocol deviations and ensuring the highest possible data quality so that together, we can improve lives.

Medical Monitoring

The creation of the Medical Monitoring Plan (MMP) includes documentation of study-specific Medical Monitoring activities to be performed, such as availability and contact details of the Medical Monitor and Marker’s medically responsible person.

We routinely assign two medical monitors to every study to provide 24/7 coverage between the primary and secondary monitors. Ongoing, our team provides support to the project via review of subject inclusion/exclusion criteria, protocol deviations, severe adverse events, lab/ECG alerts, and offers protocol clarifications, including dosing modifications and interruptions.

Medical Data Review

Our team supports cohort review and data monitoring committees, as well as clinical study report (CSR) reviews. We can also assist in the creation of the Medical Data Review plan, including eligibility review, designated safety and efficacy data, and coding review.