Supporting Better
Clinical Research
Through
Quality-Driven Services
An Independent Clinical Services Provider Driven by Precision and Accountability
Headquartered at City Vista in Kharadi, Pune, ResearchPath is a dedicated clinical research services organization. We collaborate with pharmaceutical sponsors, contract research organizations (CROs), and clinical investigator teams to manage the operational complexities of clinical trials.
Our team focuses exclusively on trial coordination, site feasibility, clinical data management, and regulatory documentation support. By coupling meticulous standard operating procedures with transparent stakeholder communication, we enable research teams to maintain strict protocol fidelity and contemporaneous documentation.
Operating purely as a clinical research operations organization, never as an educational academy.
Strategically situated in Kharadi, Pune to coordinate research activities across western and pan-India sites.
Patient-Centric Trial Coordination
“To support clinical research through dependable services, collaborative working, and a consistent focus on quality and responsible research practices.”
Comprehensive Support Across the Clinical Study Lifecycle
We deliver structured operational and administrative coordination across essential study phases. Every service is delivered in strict adherence to approved protocols and applicable regulatory frameworks.
Clinical Trial Operations Support
Operational support for trial planning, site initiation, progress tracking, and day-to-day study workflow management.
- •Study startup timeline development and milestone tracking
- •Site initiation visit logistics and documentation collation
- •Daily operational liaison between study sponsors, sites, and vendors
Clinical Research Coordination
Site-level coordination support to assist investigator teams with study documentation, subject appointment workflows, and query resolution.
- •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
Patient Recruitment Support
Ethical, protocol-compliant strategies to assist study sites in identifying, informing, and engaging prospective study participants.
- •Development of ethics-approved patient awareness and information materials
- •Design of structured pre-screening questionnaires based on eligibility criteria
- •Site-level outreach workflow optimization for referring clinicians
Clinical Data Management Support
Assisting research teams with data entry verification, electronic CRF tracking, validation checks, and query reconciliation.
- •Electronic Case Report Form (eCRF) completion tracking and backlog clearing
- •Manual and programmatic data discrepancy generation and resolution tracking
- •Source Data Verification (SDV) preparation support for clinical monitors
Site Feasibility & Selection Support
Objective evaluation of clinical trial investigator sites, assessing patient population, infrastructure, and investigative capacity.
- •Customized site feasibility questionnaire design tailored to protocol parameters
- •Site identification across diverse therapeutic areas and geographic clusters in India
- •Infrastructure verification (pharmacy storage, -80°C freezers, emergency facilities)
Regulatory Documentation Support
Support in preparing, organizing, and reviewing clinical study documentation for Ethics Committees and regulatory submissions.
- •Compilation of Institutional Ethics Committee (IEC) submission dossiers
- •Informed Consent Form (ICF) formatting and local language translation coordination
- •Subject Information Sheet (SIS) readability review and standardization
Our 4-Stage Operational Approach
Precision in clinical research requires disciplined process management. We implement a systematic four-stage methodology to ensure every milestone is clearly scoped, executed, and validated.
Understand Requirements
We perform an in-depth review of study protocols, regulatory parameters, investigator needs, and sponsor deliverables to define precise operational objectives.
Plan Agreed Scope
Establishing clear timelines, delegation logs, communication matrices, and documentation checklists before any site or data workflows begin.
Coordinate Work
Active daily coordination across investigator sites, vendors, and sponsors. Routine tracking of queries, visit milestones, and documentation collation.
Review Deliverables
Contemporaneous quality audits, reconciliation of trial records, verification against ALCOA+ standards, and structured sponsor handoffs.
Quality and Responsible Research Standards
In clinical research, quality is not a static audit checkpoint—it is an operational culture. ResearchPath approaches quality through systematic documentation verification, ethical vigilance, and risk awareness.
We adhere strictly to approved protocol parameters and applicable national regulatory guidelines, ensuring that study records are accurate, verifiable, and prepared for scrutiny.
Contemporaneous Records
Adherence to ALCOA+ documentation principles ensures records are attributable, legible, contemporaneous, original, and accurate.
Confidentiality & Privacy
Strict participant pseudonymization and secure handling protocols protect sensitive medical information and intellectual property.
Ethical Alignment
Every site activity is aligned with Institutional Ethics Committee approvals and the ethical principles of the Declaration of Helsinki.
Risk Awareness & Review
Proactive identification of protocol deviations and bottleneck risks with documented corrective and preventive action (CAPA) routines.
Integrated Quality Verification at Every Step
From initial site initiation checklists through to formal database lock, our quality team conducts ongoing reconciliations, audit readiness checks, and protocol compliance sweeps to safeguard the scientific validity of your clinical trial data.
Collaborative Support for Healthcare Stakeholders
We provide tailored operational support to diverse research entities across the clinical development ecosystem, adapting our coordination model to their organizational workflows.
Biopharma & Medical Device Sponsors
Assisting clinical development teams with site identification, feasibility assessments, regional operational coordination, and centralized milestone tracking in India.
- Objective site feasibility dossiers
- Milestone progress oversight
- Regulatory document collation
Contract Research Organisations (CROs)
Extending your operational reach with dependable on-the-ground coordination, clinical research coordinators, and data reconciliation support during peak study workloads.
- Flexible site coordination resources
- EDC query backlog reduction
- TMF filing & audit preparation
Principal Investigators & Trial Sites
Supporting clinical investigators and hospital research offices with participant scheduling, source documentation, regulatory binders, and Ethics Committee submissions.
- Subject appointment workflow management
- Investigator delegation support
- Ethics Committee submission packages
Our Clients
Trusted operational collaboration with leading global pharmaceutical sponsors, contract research organizations (CROs), and life sciences innovators.
Supporting clinical trial operations, site feasibility, and regulatory documentation across global and Indian healthcare sponsors.
Ready to Discuss Your Clinical Trial Operations Requirements?
Whether you require site feasibility assessments, clinical research coordinators, data management support, or regulatory documentation collation in India, ResearchPath is prepared to assist.