Project management is the discipline of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives. Our expertise in project management is to understand & manage the value of Cost, Quality and Timelines in Clinical Research. Our project management team ensures that you receive regular feedback and assessment of your project right through.
We offer you the following services:
Crystal Life Sciences also provides site management services to a pharmaceutical company and a biotechnology company. Our aim of managing clinical research site is to ensure adequate infrastructure and study related staff to meet the requirements of the clinical trial protocol. Some (but not all) of our responsibilities includes:
Coordinating with Bio-medical Waste Management department for waste generated due to Investigational Procedures administration.
We emphasize on protocol-specific requirements and specifications during site feasibility and PI selection.In general site identification/PI selection based upon
Training and education are first-order requirements to ensure that the Investigators, Co-Investigators, Coordinators & other site staff have a consistent and complete understanding of their roles & responsibilities for clinical trials.During the site training, we emphasize on the following points while considering protocol specific requirements.
Coordinating with Bio-medical Waste Management department for waste generated due to Investigational Procedures administration.
We are implementing and maintaining QA & QC systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded) and reported in compliance with the protocol, ICH GCP/ Schedule Y and the applicable regulatory requirements. Crystal Lifesciences QA/QC Department performs system audits, in-process audits and retrospective audits to assess adherence and compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), regulatory requirements and contractual obligations.Quality control system verifies and ensures that study data is reliable and retrievable, that instructions and standards are implemented and adhered to, and that appropriate corrective and preventive actions are taken.
We place a full-time, highly qualified clinical research coordinator at each study site to assist the investigators and site staffs with all day-to-day study conduct activities. Our coordinators are trained to provide professional support to the investigator ensuring compliance with FDA,local regulatory and ICH-GCP guidelines and efficient completion of assigned duties. The study coordinators are experienced in Electronic Data Capture (EDC) based trials. This helps in accurate data entry and thereby reducing queries from data management departments. Our Project Management and Quality Management Team carry out constant internal monitoring at the various sites to facilitate the documentation efficiently. This ensures collection of high quality study data necessary for regulatory and product approval submissions.
Crystal Life Sciences also provides services of language translation/back translation from English to Hindi and English Marathi and vice versa for the contents related to the clinical trial.