Strategic Site Identification & Feasibility Analysis
The success of any clinical trial rests on the foundation of the right site. At PTCCR, we don't just find hospitals; we identify high-potential research centers. Our feasibility team conducts deep-dive audits of potential sites to assess infrastructure (storage, labs), investigator experience, and actual patient availability. We ensure that every site selected is fully capable of meeting enrollment targets and protocol requirements before the study begins.
Key Deliverables:
Infrastructure & Facility Audit.
Investigator Qualification (GCP Compliance)
Patient Population Analysis.
Competitor Trial Assessment.
Accelerated Patient Recruitment & Retention
Patient recruitment is often the biggest bottleneck in clinical research. We proactively address this by deploying site-specific recruitment strategies. Our teams engage with the community, utilize patient databases, and implement counseling programs to ensure patients not only join the study but complete it. We prioritize diversity and ethical consent processes to ensure robust trial data.
Key Deliverables:
Database Screening & Referral Networks.
Patient Education & Counseling.
retention Strategies to minimize drop-outs.
Informed Consent Support.
Ethics Committee Registration Management
Navigating the regulatory landscape of the CDSCO (Central Drugs Standard Control Organisation) and DHR (Department of Health Research) is complex. PTCCR takes full ownership of the Ethics Committee (EC) registration process. We handle the documentation, submission, and follow-up required to obtain initial registration and timely re-registration, ensuring your site remains compliant and authorized to conduct research without legal interruptions.
Key Deliverables:
DHR & CDSCO Registration Filings.
Re-registration Timeline Management.
Documentation Gap Analysis.
Regulatory Liaison.
Standardization of EC Standard Operating Procedures
A functional Ethics Committee requires robust Standard Operating Procedures (SOPs). We draft, review, and standardize SOPs for Institutional Ethics Committees to ensure they meet the latest New Drugs and Clinical Trials Rules (2019). We create customized SOPs that cover constitution, review procedures, decision making, and record keeping, ensuring the EC operates at the highest ethical standard.
Key Deliverables:
Custom Drafting of SOPs.
SOP Revision & Version Control.
Alignment with ICMR & GCP Guidelines.
EC Member Training on SOPs.
Comprehensive Regulatory & IRB Submissions
Timely approvals define trial start dates. Our regulatory team manages the entire submission lifecycle for Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs). From initial protocol submissions to safety reporting (SAE) and protocol amendments, we ensure all dossiers are accurate, complete, and submitted on time to prevent administrative delays.
Key Deliverables:
Initial Protocol Submission Packages.
Serious Adverse Event (SAE) Reporting.
Protocol Amendment Submissions.
Query Resolution.
End-to-End Trial Operations & Monitoring
This is the core of what we do. Our Project Managers and Clinical Research Coordinators (CRCs) oversee the day-to-day operations at the site. We ensure strict adherence to the protocol, manage investigational product (drug) accountability, and maintain the Investigator Site File (ISF). Our monitoring ensures that the trial runs smoothly, efficiently, and safely.
Key Deliverables:
Site Initiation Visits (SIV).
Source Data Verification (SDV).
Drug/Device Accountability.
Site Close-Out Visits.
Clinical Data Management & Quality Assurance
Data is the product of clinical research. We implement rigorous Quality Assurance (QA) systems to ensure your data is accurate, attributable, and audit-ready. Whether using paper CRFs or Electronic Data Capture (EDC), our team conducts regular quality checks to ensure zero-error data entry and immediate query resolution.
Key Deliverables:
Electronic Data Capture (EDC) Entry.
Internal Data Audits.
Query Generation & Resolution.
Source Document Verification.
GCP Training & Skill Development
A well-trained site is a compliant site. PTCCR provides ongoing training for Investigators, CRCs, and site staff. We conduct workshops on Good Clinical Practice (GCP), recent regulatory updates, and protocol-specific procedures. This ensures that everyone involved in the trial is competent and aware of their ethical responsibilities.
