eCDS
Introduction
In clinical research, the distribution and tracking of investigational drugs is a complex task involving multiple stakeholders and requiring meticulous documentation. Current practices are still largely dependent on fragmented tools such as emails, spreadsheets, and unconnected supplier portals, which makes the process inefficient and error-prone.
The eCDS platform proposes an integrated and automated workflow that enhances communication, ensures complete traceability, and simplifies all phases of drug supply management for clinical trials.
Current Challenges: A Fragmented, Manual Process
As of today, site staff must handle drug requests manually—communicating quantities and needs via email or supplier-specific portals. Suppliers respond with details such as batch numbers and expiration dates, which are then copied into internal files and relayed to depots and clinical sites. Confirmations, approvals, and return logistics are also processed through unstructured documents, typically Excel files or PDFs.
This results in a lack of real-time visibility, increased administrative burden, and potential compliance risks during audits.
The Proposed Solution: A Centralized Digital Workflow
eCDS reimagines the entire process by offering a structured, digital environment where every action is tracked and linked to the relevant stakeholders, documents, and product batches. When a new study is initiated, all relevant data—drug types, clinical sites, suppliers, depots, and waste disposal centers—are entered into the platform.
Initial drug orders are created within eCDS and automatically sent to suppliers via email. Although suppliers may still require manual entry into their proprietary platforms, the goal is to evaluate integration options on a case-by-case basis.
Clinical sites log into the platform to submit their requests. Study personnel review and approve quantities, triggering the generation of a PDF order form which is sent to the depot and requester. Depots may respond through an embedded online form, specifying batch numbers, serial numbers, and expiry dates.
Drug receipt confirmations are also handled digitally. Sites upload the signed delivery documents to the platform, which automatically sends confirmation emails to depots and study personnel.
One of the most valuable features is automated expiry tracking: the system sends alerts to site and sponsor teams when batches approach their expiration date. A dedicated return and disposal module enables the logistics of product return, tracking of parcel reception, and final disposal confirmation—each step accompanied by documentation and automated communication.
Key Features and Benefits
eCDS ensures full traceability of every drug package by batch, serial number, and destination site. The entire supply chain is monitored in real-time, reducing administrative workload, improving data quality, and enhancing operational readiness.
By digitizing and standardizing drug supply processes, the platform lowers the risk of waste, delays, and non-compliance, especially in complex or multinational clinical trials.
Conclusion
eCDS is a significant leap forward in modernizing investigational drug management in clinical research. With an intuitive interface and a robust backend for data integrity and traceability, the platform empowers trial teams to operate more efficiently and transparently. Future roadmap items include integrations with supplier systems and advanced analytics, paving the way for intelligent and centralized control of the clinical supply chain.