Project Management
Effective project management is essential for the successful execution of clinical trials, ensuring adherence to timelines, budgets, and quality standards. At Equilab, our dedicated project management team oversees all aspects of trial planning, implementation, and monitoring. We utilize best practices to drive optimal outcomes.
Clinical Monitoring: Site Initiation Visit (SIV), Monitoring Visit (MV), Remote Monitoring, Close Out Visit (COV)
6.
Equilab’s project management team coordinates all aspects of clinical monitoring activities, including Site Initiation Visits (SIVs), Monitoring Visits (MVs), Remote Monitoring Visits (RMVs), and Close-out Visits (COVs). We ensure that monitoring activities are conducted efficiently and in accordance with study requirements, GCP guidelines, while providing ongoing support and oversight to site staff and study personnel.
Investigational Product and Sample Management
5.
Equilab oversees the management of Investigational Products (IPs) and study samples, from receipt to disposal. Our personnel ensure proper handling, storage, and distribution of investigational products, as well as timely collection, processing, and shipping of study samples in accordance with protocol requirements.
TMF Set-Up and Maintenance
4.
Equilab’s project management team ensures the completeness, accuracy, and integrity of TMF documentation throughout the trial lifecycle, thereby facilitating inspection readiness and regulatory compliance.
GCP Training and On-site Coordination
3.
Equilab ensures compliance with ethical and regulatory standards by providing Good Clinical Practice (GCP) training to site staff, study personnel, and our Clinical Research Associates (CRAs), who are also regularly trained. Our project managers coordinate on-site training sessions and provide ongoing support and guidance, ensuring that all trial activities align with GCP principles.
We assess clinical laboratory capabilities and infrastructure to ensure the selection of qualified laboratories capable of performing necessary analyses and assays for the trial. Our team coordinates laboratory agreements and oversees ongoing laboratory operations to ensure adherence to study protocols and regulatory requirements.
Clinical Laboratory Feasibility and Selection
2.
Site Feasibility, Selection, Agreement, and Management
1.
Our project management team conducts comprehensive site feasibility assessments to identify suitable sites for participation in clinical trials. We manage the site selection process, negotiate agreements, and establish effective communication channels to facilitate collaboration between sponsors, investigators, and site staff throughout the trial duration.