Medical365 clinical trial management software manages GCP compliance, patient screening logs, electronic source data (eSource) & SAE reporting for Indian cancer hospitals.
Clinical trial management software (CTMS) is a specialized clinical research module designed for comprehensive cancer research institutes and academic hospitals. It manages ICH-GCP compliant trial protocols, subject screening and randomization logs, electronic source data capture (eSource), Serious Adverse Event (SAE) reporting to regulatory authorities (CDSCO / DCGI), and investigational product (IP) accountability.
Addressing high-volume OPD congestion, diagnostic fragmentation, and statutory healthcare regulations.
Clinical trials in oncology provide cancer patients with access to breakthrough novel therapeutics—including immunotherapy checkpoint inhibitors, antibody-drug conjugates (ADCs), and CAR-T cell therapies—years before commercial availability. In Indian academic medical colleges and cancer research centers, oncologists lead multi-center international and investigator-initiated clinical trials.
However, conducting clinical trials carries immense regulatory scrutiny and documentation overhead. Clinical investigators and study coordinators must comply with strict International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and Central Drugs Standard Control Organisation (CDSCO) regulations. Recording research data on paper case report forms (CRFs) is labor-intensive, invites transcription errors during monitor audits, and risks regulatory penalties if Serious Adverse Events (SAEs) are not reported within mandatory 24-hour statutory windows.
Medical365's Clinical Trial Management module bridges everyday patient care with clinical research compliance. Featuring automated inclusion/exclusion eligibility screening, electronic informed consent (eICF), audit-proof eSource clinical documentation, investigational drug accountability logs, and automated 24-hour SAE notification engines, Medical365 empowers cancer centers to conduct world-class clinical research with absolute regulatory confidence.
Engineered with medical sub-specialists to eliminate manual charting friction and enforce clinical protocol rigor.
Pre-configures trial-specific inclusion and exclusion criteria, automatically cross-referencing patient histology, stage, prior lines of therapy, and lab values to flag eligible trial candidates.
Complies with CDSCO Indian clinical trial mandates requiring audio-visual recording of informed consent for vulnerable populations, securing timestamped biometric/digital signatures.
Enables direct electronic source data entry with 21 CFR Part 11 compliant immutable audit trails, capturing user ID, timestamp, and rationale for any retrospective data modification.
Standardized CTCAE v5.0 adverse event grading (Grade 1-5) with automated countdown timers and pre-formatted regulatory reporting templates for CDSCO, Sponsor, and Institutional Ethics Committee (IEC).
Tracks investigational drug shipments: temperature log verification, bottle/vial serial numbers, dispensing logs, patient return counts, and pill destruction certificates.
Calculates exact study visit windows (e.g. Cycle 2 Day 1 ± 2 days) based on protocol rules, alerting study coordinators to upcoming pharmacokinetic (PK) blood draws and imaging windows.
High-resolution data flow architecture connecting point-of-care capture, diagnostic instruments, and national health registries.
A transparent 5-stage digital pathway standardizing patient care from initial requisition to longitudinal review.
Oncologist reviews protocol criteria; software cross-checks patient chart and confirms trial eligibility.
Clinical research coordinator conducts informed consent discussion; audio-visual record and digital signature are archived.
Subject assigned unique trial ID; investigational product dispensed with barcode verification at research pharmacy.
Study coordinator logs protocol-specific vitals, toxicity scores (CTCAE), and lab draws directly into eSource forms.
Any adverse event auto-grades; SAEs trigger instant automated alert to Principal Investigator and Ethics Committee.
Medical365 Clinical Trial Management complies with CDSCO New Drugs and Clinical Trials Rules 2019, ICH-GCP E6(R2) standards, US FDA 21 CFR Part 11 electronic records regulations, and Indian Council of Medical Research (ICMR) ethical guidelines.
All trial data, audit logs, and electronic signatures are secured under AES-256 encryption compliant with the DPDP Act 2023. Patient summaries integrate with national ABDM health records.
See how automated digital intelligence transforms efficiency, reduces diagnostic turnaround times, and protects clinical revenue.
| Feature / Requirement | Conventional Manual Practice | Medical365 EMR Solution ★ |
|---|---|---|
| Subject Screening |
✕ Manual Method: Manual chart review of paper files; many eligible candidates missed |
✓ Medical365 Solution: Automated electronic screening flagging patients matching protocol criteria |
| Audit Trail & Compliance |
✕ Manual Method: Paper source documents with manual correction marks and missing dates |
✓ Medical365 Solution: 21 CFR Part 11 compliant immutable audit trail tracking all edits |
| SAE Reporting |
✕ Manual Method: Typing Word documents under tight deadlines; high risk of missing 24h window |
✓ Medical365 Solution: Automated 24-hour SAE clock generating pre-formatted CDSCO/IEC reports |
| Drug Accountability |
✕ Manual Method: Paper logbooks prone to arithmetic errors during sponsor monitoring visits |
✓ Medical365 Solution: Digital barcode tracking of received, dispensed, and returned study drug |
| Visit Window Scheduling |
✕ Manual Method: Manual calculation of study visit calendar; risk of protocol deviations |
✓ Medical365 Solution: Automated protocol calendar calculating exact visit windows (± days) |
Seamless bidirectional data sharing across all hospital clinical departments and diagnostics.
Clinical, technical, and regulatory answers for hospital directors and medical specialists.
Under Indian clinical trial regulations, audio-visual recording of informed consent is mandatory for new drug trials involving vulnerable subjects. Medical365 includes built-in webcam/tablet recording that encrypts and securely stores the AV consent file alongside the signed digital consent document.
Yes. Medical365 includes strict access controls, unique user credentials, automated session timeouts, electronic signatures, and tamper-proof computer-generated audit trails recording the date, time, user, and reason for every data modification.
When an investigator logs an event classified as serious (death, life-threatening, hospitalization, disability, or congenital anomaly), the software starts a 24-hour countdown and drafts pre-filled regulatory reporting packages for the CDSCO, Ethics Committee, and Trial Sponsor.
Yes. The system provides secure, role-based remote monitoring portals for Sponsor CRAs, allowing source data verification (SDV) and query resolution without exposing non-trial patient data.
The pharmacy module logs daily min/max refrigerator and room temperature readings, automatically flagging temperature excursions and holding affected drug batches from being dispensed.
Yes. Principal investigators can use the visual form builder to configure custom Case Report Forms (eCRFs), eligibility checklists, and visit schedules for academic research in under an hour.
