CRO-Sponsors/ Investigator Sites(Hospitals)
Sponsors & CRO
Feasibility & site Selection
The feasibility process is the fundamental of our project management. CCRSPL has worked on effectively every therapeutic area and has an association with key investigators and trial sites. We select the best investigative sites to manage a clinical trial with the help of our efficient feasibility assessment process. We have well-experienced feasibility and site selection team to visit the sites and examine the site facilities for managing clinical trials.
Handling Budget for Site
Budget is a very crucial task in project management. CCRSPL has experts on handling budget in their team. The team helps sites or work as a connector between sponsor and site.
Preparation of regulatory document
Our experienced CRC’s are well versed to regulatory guidelines and timelines of our associates. Hence CCRSPL provides regulatory services to our associates in stipulated conditions & timelines.
Project management : Start up to close out
CCRSPL has highly trained and experienced staff for project management. Our goal is to ensuring quality in project management along with a timeline of associates. Our team makes sure that they have successfully managed a clinical trial with quality, ethics & guidelines. With their proactive approach toward clients helps them to address in detailed risk assessment and mitigation plan.
Quality Assurance/ monitoring
CCRSPL team makes sure to maintain accuracy and quality throughout the conduct clinical study. CCRSPL has maintained the process of QA by its Project manager throughout the trial. Also, project manager helps CRC to prepare the site for Sponsor monitoring or audit.
CCRSPL expert’s staff prepared regulatory documentation as per requirement Ethics committee submission. We follow the EC SOP and guidelines. Manages the hurdles to get approval from EC in timeline
Investigator or Sites
Providing expert staff on Clinical Research
Clinical researchers can add on some expertise resource for complex trials for more guidance and assistance partnership with investigators, and get knowledge of study design, initiation
CCRSPL have a trained and experienced quality assurance team who strictly follows all the rules and regulations.we follow stringent Standard Operating Procedures (SOPs) for every step of the clinical trial.
Archival Support as per the Guidelines
CCRSPL act as 3 party vendor for archival of clinical study documents as per the requirement of our associates & guidelines.
standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization. In clinical research, SOPs help defines the group’s (e.g., unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidelines.
SOPs should contain adequate detail to clearly guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. Each SOP should have a specific aim but be written in a general format that can be easily followed by a broad audience. By laying out defined processes, the primary function of an SOP is to specifically avert procedural deviations.
Project management team support to investigator
CCRSPL’s project management team have some responsibilities. Their primary goal is to accomplish the tasks allocated to them by the project manager. The progress of the task should be discussed with the lead by the members, and if there is any problem or changes the team expected to inform it immediately to the Manager.
Our team knows the importance of their roles and responsibilities which helps to make the project successful.