Clinical Research Coordination
Site-level coordination support to assist investigator teams with study documentation, subject appointment workflows, and query resolution.
What This Service Involves
Investigator sites require dedicated administrative and operational support to handle protocol complexities while maintaining the highest standard of patient safety and documentation precision. ResearchPath provides qualified clinical research coordination support to streamline site activities and ensure smooth protocol compliance.
Who It Is Intended For
Scope of Support
Our team provides disciplined coordination across the following agreed operational parameters:
- Subject appointment scheduling and protocol visit timeline management
- Informed consent documentation support under investigator oversight
- Assistance with Case Report Form (CRF / eCRF) completion and query tracking
- Investigational product accountability log maintenance under site supervision
- Coordination of laboratory sample handling and courier logistics documentation
- Organization of site regulatory binders and Trial Master File (TMF) documents
Operational Workflow Stages
Protocol Immersion
Comprehensive site-level review of the trial protocol, visit schedules, and inclusion/exclusion criteria.
Site Setup & Tools
Preparation of patient visit workbooks, source document templates, and appointment schedules.
Study Visit Facilitation
Coordinating participant visits, supporting documentation completeness, and tracking lab requisitions.
Query Resolution & Audit Readiness
Promptly resolving sponsor queries and ensuring site documentation is continuously audit-ready.
Expected Deliverables
- All activities are performed strictly under the delegation and supervision of the Principal Investigator
- Protection of participant rights, privacy, and informed consent verification
- Immediate escalation of adverse events or anomalies directly to the investigator
- Contemporaneous, attributable, legible, original, and accurate (ALCOA+) documentation practices
Note: ResearchPath provides coordination and operational support. We do not provide guarantees regarding regulatory approval decisions, trial clinical efficacy, or patient recruitment targets.
Frequently Asked Questions
Who oversees the clinical research coordinator?
The Principal Investigator holds ultimate medical and regulatory responsibility for the study. Our coordinators operate strictly within the investigator delegation log.
Do coordinators interact directly with study patients?
Coordinators assist with logistics, appointment scheduling, and procedural explanations under investigator supervision, but medical assessments and informed consent decisions are always led by the investigator.
Discuss Your Clinical Requirements
Provide your study parameters or operational needs below. Our clinical operations team will review your specifications and contact you directly.
Important Notice: This portal is dedicated strictly to organizational, sponsor, and investigator inquiries. Please do not submit patient-identifying health information (PHI) or personal medical records through this form.
Operational Office
406, B Wing, City Vista, Kharadi, Pune, Maharashtra, India.
Phone: +91 91464 52014
Email: info@researchpath.in