Control the Complexity
Labeling an Investigative New Drug (IND) / Investigative Medical Product (IMP) or an Investigative Medical Device for clinical trials is a complex process requiring well-documented procedures and careful oversight. Required label information can vary based on whether it is an open or blind trial, the phase of the trial and where the clinical trial is located. For pharmaceutical companies and Contract Research Organizations (CRO), this can be a time-consuming and labor-intensive process requiring frequent updates throughout the trial process.
Loftware’s solutions ease the management of required label content and translations while helping you meet requirements for Good Manufacturing Processes (GMP), such as the EU’s Annex VI and FDA’s 21 CFR Part 211. Labeling errors can delay trials, waste product or even invalidate results, potentially costing millions. Accuracy of label content, auditability of procedures and traceability of the drug throughout the trial are critical.
Loftware offers solutions to help manage the challenges of clinical trial labeling, improving accuracy and traceability, reducing waste and shortening time-to-market.
Loftware solutions allow you to:
- Automate labeling processes, including changes, review and approvals, with advanced workflows that also support audit tracking and reporting
- Ensure that the right information is included on the right label with powerful and configurable business logic
- Bring order and process to managing translations with version-controlled phrase library
- Guarantee that only approved labels and content are used with built-in version control
- Find defects more accurately and more efficiently than is possible with the human eye using automated proofing capabilities
- Provide consistency and accuracy and eliminate data duplication with centralized content management