Services

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:

1. Cost Assessment
2. Budgeting and Negotiation
3. Development of Timelines
4. Recruitment Strategy
5. Project Tracking & Team Meetings
6. Scheduling
7. Proactive issue identification and quick resolution on timely basis
8. Protocol Compliance training for study staff
9. Evaluation of Customer Feedbacks and to take necessary actions
10. Identify and prioritize financial, technical, and legal risks to ensure project success
11. Develop good communication practices throughout the trial
12. Practical approach for maintaining regulatory compliance and implement best practices to follow the Good Clinical Practices (GCP).

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:

1. Submissions to Ethics Committee
2. Patient registration and randomization through IVRS/IWRS.
3. Patient Recruitment
4. Scheduling patient visits as per protocol schedule of events.
5. Trial subject follow up
6. Subject Retention Policies
7. Coordinating laboratory sample collection/pick up schedules with local and central laboratory.
8. Case Report Forms (CRF) completion.
9. Trial-related documents archival and maintenance
10. Reporting serious adverse events to the Sponsor and EC
11. Ensuring protocol compliance
12. Advising & alerting investigators of potential protocol violations
13. Advising & alerting investigators of potential ICH-GCP violations
14. Identifying potential eligible patients and short-listing of patients for chronic diseases
15. Maintenance of the essential documents at the site.
16. Queries resolution within the timelines fixed by Sponsor
17. Evaluating patient status for safety and assure optimum health care
18. Investigational product management, dispensing, temperature monitoring and accountability
19. To maintain and submit the progress report of the trials to the Ethics Committee.
20. To maintain and submit revisions & amendments of trials related documents to Ethics Committee.
21. To maintain & document relevant communications with Sponsors/CRO i.e. meeting notes, letters and telephone calls.
22. To assist the sponsor’s designated representative during site selection visit, site initiation visit and study close out visit.
23. Preparation, attendance and follow-up of monitoring
24. Preparation, attendance and follow-up of Audit
25. 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.

We emphasize on protocol-specific requirements and specifications during site feasibility and PI selection.In general site identification/PI selection based upon

1. Patient Pool
2. Investigator's qualification, trial experience and interest
3. Papers published by the Investigator
4. Hospital infrastructure and resources
5. ICH/GCP trained staff availability
6. Basic qualification of the site staff
7. Investigator's and site's previous experience on clinical trial
8. Ethics committee structure and timeline
9. Evaluation of Customer Feedbacks and to take necessary actions
10. Accessibility to the site
11. Central Laboratory services

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.

1. ICH-GCP, Schedule Y, ICMR Code and other regulatory guidelines training which includes ICF, Source documents, CRF,CT Documents,SMF, AE, Drug accountability, Roles and responsibilities etc.
2. Protocol/ study specific training
3. SAE reporting and safety management.
4. EDC Training
5. IVRS/IWRS
6. Central Laboratory Sample Management

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.