CO.DON AG
DGAP-News: CO.DON AG / Key word(s): Miscellaneous CO.DON AG develops MECDOX software solution for the end-to-end digitalisation of pharmaceutical processes Berlin / Teltow, 24.10.2018 - One particular feature associated with the manufacture of Advanced Therapy Medicinal Products (ATMP) is the scope and complexity of the documentation required for the accompanying processes. In addition to monitoring and registering physicians and hospitals with the authorities, this entails obtaining formal informed consent from patients before the treatment, documenting the production activities and quality controls, as well as ensuring the traceability of material from and to the patient. These processes are mostly paper-based, required for every individual patient, and to date could only be monitored and checked manually. This time and personnel resources required by this are very high. Now it is possible to digitalise the support processes for manufacturing ATMP safely and in a controlled environment, without compromising conformity with the numerous regulatory demands. In cooperation with IT partners, CO.DON is developing the software solution MECDOX. The system meets all pharmaceutical and regulatory requirements in full and complies with the strict data protection provisions of the GDPR (General Data Protection Regulation). MECDOX is not a classical electronic document management system (eDMS), but rather a completely new software solution, which covers and supports the specificities of ATMP business processes in a much more reliable way, without any restrictions on conformity. MECDOX will seamlessly cover the process chain between physicians, hospitals and CO.DON. Both the documentary processes required for regulatory purposes and the company's logistic and product traceability processes are digitalised, from the biopsy through to the transplant. Another key advantage is the ability it gives all user groups to communicate directly with one another. MECDOX will not only support the correct execution of processes, but also monitor these processes reliably and continuously. This secure, precise monitoring prevents departures from the defined process, significantly improves the consistency of routines and so boosts efficiency and saves costs. The non-proprietary software architecture means MECDOX is not a silo limited to CO.DON, but can with modifications be used in many areas of personalised, regenerative and transplantation medicine. CO.DON AG develops, produces and markets autologous cell therapies for the minimally invasive repair of cartilage defects. The product being marketed is a cell therapy product that uses only the patient's own cartilage cells ("autologous chondrocytes"). CO.DON's method is currently used in over 200 clinics in Germany and more than 14,000 patients have already been treated. In July 2017 we received marketing authorisation for the advanced therapy medicinal product Spherox from the European Medicines Agency. The shares in CO.DON AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). Executive Board: Ralf M. Jakobs. Further information is available from www.codon.de Investor Relations and Press Contact:
24.10.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
| Language: | English |
| Company: | CO.DON AG |
| Warthestraße 21 | |
| 14513 Teltow | |
| Germany | |
| Phone: | 03328 43460 |
| Fax: | 03328 434643 |
| E-mail: | info@codon.de |
| Internet: | www.codon.de |
| ISIN: | DE000A1K0227 |
| WKN: | A1K022 |
| Listed: | Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Stuttgart, Tradegate Exchange |
| End of News | DGAP News Service |
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