Our Development and Medical Services team brings industry-leading knowledge and expertise to design, plan and implement innovative, patient-centric solutions for drug and device development. We believe in collaboration, understanding client’s goals and expectations and work together to develop tailored solutions supporting their unique needs. We strive to adopt new technologies and emerging scientific insights that can facilitate efficient trials designs and execution to improve the likelihood of regulatory success.
Our team’s expertise would support in:
- Clinical drug development strategy, from first in human through phase IV and post marketing follow-up
- Study designs, protocol development with a focus on optimization of the development process in collaboration with epidemiology and statistical functions.
- Providing input in clinical development plans (CDP) and risk assessments
- Medical monitoring with expertise in data reviews
Our well-experienced medical monitors (MDs) support wide range of therapeutic areas for successful execution of clinical studies. Medical monitoring services include:
- Oversight of study conduct to confirm that the execution is as per the study protocol and is GCP compliant.
- Identify study risks and participate in mitigation strategies
- Continuous monitoring of patient safety which includes AEs and SAEs reported in clinical and safety database, lab data and alerts, ECG and other study specific data
- Support to answer questions regarding safety and enrollment/eligibility in the study.
- Ensuring data integrity by thorough data review and analyzing safety and efficacy trends
- Collaborating with investigators and site research teams
- Providing medical leadership to sites by answering investigator questions about the protocol and the medical management of subject emergencies, including emergency unblinding or safety related questions
- Medical support to signal detection activities
- Independent medical monitoring for safety reviews and participate in Independent Data Monitoring Committee (IDMC)
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