Crystal Life Sciences Hadapsar, Pune, Maharashtra

We emphasize on protocol-specific requirements and specifications during site feasibility and pi selection.in general site identificationpi selection based upon patient pool investigator's qualification, trial experience and interest papers published by the investigator hospital infrastructure and resources ichgcp trained staff availability basic qualification of the site staff investigator's and site's previous experience on clinical trial ethics committee structure and timeline accessibility to the site central laboratory 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: submissions to ethics committee patient registration and randomization through ivrs/iwrs. Patient recruitment scheduling patient visits as per protocol schedule of events. Trial subject follow up subject retention policies coordinating laboratory sample collection/pick up schedules with local and central laboratory. Case report forms (crf) completion. Trial-related documents archival and maintenance reporting serious adverse events to the sponsor and ec ensuring protocol compliance advising & alerting investigators of potential protocol violations advising & alerting investigators of potential ich-gcp violations identifying potential eligible patients and short-listing of patients for chronic diseases maintenance of the essential documents at the site. Queries resolution within the timelines fixed by sponsor evaluating patient status for safety and assure optimum health care investigational product management, dispensing, temperature monitoring and accountability to maintain and submit the progress report of the trials to the ethics committee. To maintain and submit revisions & amendments of trials related documents to ethics committee. To maintain & document relevant communications with sponsors/cro i.e. Meeting notes, letters and telephone calls. To assist the sponsor’s designated representative during site selection visit, site initiation visit and study close out visit. Preparation, attendance and follow-up of monitoring preparation, attendance and follow-up of audit trial closeout: preparation, attendance and follow-up; forwarding the necessary information of closeout to clients. coordinating with bio-medical waste management department for waste generated due to investigational procedures administration.

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: cost assessment budgeting and negotiation development of timelines recruitment strategy project tracking & team meetings scheduling proactive issue identification and quick resolution on timely basis protocol compliance training for study staff evaluation of customer feedbacks and to take necessary actions identify and prioritize financial, technical, and legal risks to ensure project success develop good communication practices throughout the trial practical approach for maintaining regulatory compliance and implement best practices to follow the good clinical practices (gcp).