Project Management:-

We believe that excellent project management and execution is the ingredient for successful delivery of a project/milestone. Our Project Managers (PMs) work closely with the Sponsor team to understand their expectations, and meticulously plan/customize the study deliverables. They act as one stop solution for all project needs, thus, enhancing efficiency, negating communication gaps and improvising turnaround time. Our PMs are exceptional people managers. Excellent people management along with technical acumen is key to prolific outcome of a deliverable/project.

Regulatory Affairs:-

ClinPro team is well versed with Indian regulatory guidelines and procedures and possess the knowhow in addressing regulatory queries and seeking approvals with quick turnaround time. Our team is adept in preparing dossiers for regulatory submissions, obtaining clinical trial NOC and import license, submitting study progress/SAE reports in a timely manner and various other regulatory activities and submissions. We have established good credibility and rapport with the central licencing authority in India. Out team has hands on expertise in Indian regulatory portals, which is an added advantage for study registration and other requests/submissions.

Medical Writing:-

We provide medical writing services for trial, regulatory, marketing and publication content. These can be a part of full-service project or standalone functional service as well. Our medical writing experts can support in creating the following documents/reports, but not limited to:

• Protocol and amendments
• Case report forms
• Subject diaries
• Inform consent form and supporting documents
• Clinical study report
• Feasibility reports
• Investigator brochure
• Comprehensive summary for regulatory submission and presentation
• Newsletters
• Training modules
• Flash card and visual aids
• Abstracts, posters etc.

Medical Monitoring:-

Our highly qualified and experienced medical monitors play a vital role throughout the conduct of the trial, from a safety perspective. They train the study team on the protocol and therapeutic indication. They provide medical and scientific support to the sites and project teams, assist in medical inputs for regulatory submissions and safety reporting to authorities, provide timely response to investigator queries etc. They conduct an ongoing evaluation of safety data like adverse events, labs, medications etc. along with medical review of SAEs, narratives and follow ups.

Safety and Pharmacovigilance:-

Our safety processes are guided by robust and well-defined Safety Management and Reporting plan. We ensure timely submission of safety information to regulatory authorities, sponsor, and ECs. Our safety team works closely with the medical monitor, from SAE occurrence till resolution. We maintain meticulous tracking of the receipt and acknowledgement of investigator alert letters (IALs) and CIOMS.

Clinical Trial Supplies Management:-

Timely availability, efficient storage, tracking and inventory of clinical trial supplies is a crucial aspect for seamless continuity of a trial. We conduct thorough logistics planning of IP, lab supplies, study equipment etc. to ensure timely delivery and adequate quantity availability of supplies at the investigator sites. We supervise the site IP storage facility to verify storage conditions as prescribed in the IP storage guidelines. Batch and subject level reconciliation of IP is performed to validate IP compliance. It is ensured that expired/damaged IP is quarantined and stored at a separate location.

Biostatistics and Programming:-

Our suite of biostatistics and programming includes the following tasks, but not limited to:

• Creating Statistical Analysis plan
• Support is creating trial design
• Sample size determination
• Creating randomization plan
• Interim analysis- data monitoring committee meetings
• Develop SDTM and ADaM datasets
• Database lock support
• SAS programming
• Statistical input on Clinical Study Report (CSR)
• Review of Tables, Listings and Graphs (TLGs)

Third-Party Vendor Management:-

Clinical research is an enormously huge domain, and it involves smooth coordination and rapport building with a host of third-party vendors. We, at ClinPro are aware of this, and have built excellent collaborations and seamless working relations with our vendors, who have been meticulously selected via our robust vendor evaluation and selection process. This enables us to meet our goal of providing proactive, prompt and proficient clinical trial services to our customers.