At Sapientia Medicus Research, we specialize in clinical research, offering a range of core services to support the successful execution of clinical trials in hospital settings. Our services ensure efficient site operations, regulatory compliance, and the delivery of high-quality results within established timelines.
PI Selection: Evaluating potential PI for their suitability based on study requirements, capabilities, and patient population.
Feasibility Analysis: Conducting feasibility studies to determine the site's ability to meet the study’s needs, including assessing patient recruitment potential.
Ethics Committee Submissions: Preparing and submitting documents to ethics committees for approval.
Compliance Monitoring: Ensuring adherence to study protocol, Good Clinical Practice (GCP) guidelines, regulatory guidelines, and sponsor requirements.
Recruitment Strategies: Designing and executing accelerated recruitment strategies to swiftly enroll eligible patients in clinical trials, ensuring timely and efficient study progression.
Retention Programs: Creating and managing effective strategies to keep patients engaged and committed throughout the entire study.
Study Coordination: Managing the daily operations of clinical trials, including scheduling, logistics, and stakeholder coordination to ensure smooth and efficient study execution.
Problem Solving: Identifying and resolving challenges that arise during the study to maintain progress and achieve study objectives.
Data Collection: Ensuring the accurate and timely gathering of study data from clinical sites.
Electronic data capture: Proficient in using electronic data capture (EDC) systems, including iMedidata, Veeva Vault, Octalsoft, Oomnia, etc. To streamline data management and enhance study efficiency
Documentation: Managing essential documents related to patient consent, site agreements, and study conduct.
Record Keeping: Ensuring accurate and secure storage of study records for regulatory compliance and future reference.
Training Programs: Delivering comprehensive training for site staff on study protocols, regulatory guidelines, and best practices to ensure smooth and compliant study operations.
Monitoring Visits: Performing routine site visits to verify adherence to study protocols and regulatory standards, ensuring the integrity and quality of the clinical trial.
