Telekom and Boehringer Ingelheim are optimizing clinical studies

Clinical drug studies demonstrate the efficacy and safety of a medication. They are a crucial aspect of pharmaceuticalresearch. Boehringer Ingelheim, Germany's largest pharmaceutical company, and Telekom are optimizing these studies.

Clinical drug studies are an essential and central element of pharmaceutical research as they validate and ensure the efficacy and safety of a medication. Telekom has developed the documentation system TrialComplete Early Phase in collaboration with Boehringer Ingelheim for conducting Phase I studies, which will be used for the first time at the Human Pharmacological Center in Biberach an der Riss.

"We developed TrialComplete Early Phase together with Telekom to continue electronically capturing study data in the future,"says Dr. Dr. Nadine Beetz, head of the Human Pharmacological Center at Boehringer Ingelheim. "The solution will help us collectand process data quickly, effectively, and securely in our Phase I studies. Paper documentation is largely a thing of the past, andthe high availability of data in electronic form supports the safety of participants in our studies and accelerates the executionand evaluation of data. The feedback from our involved teams after the initial studies with TrialComplete Early Phase has been extremely positive."

Phase I studies, which also include first-in-human studies, are typically conducted on healthy volunteers. In this phase, thefundamental properties of a new drug, including its tolerability and safety, are thoroughly examined to determine its suitabilityfor human application.

Protected Location-Independent Data Access

TrialComplete Early Phase is a GCP-compliant documentation system for setting up Phase I studies and for the collection,analysis, and reporting of data within these studies conducted at Boehringer Ingelheim's Human Pharmacological Center inBiberach.
"All data and evaluations are standardized and stored on a central platform that can be accessed by any authorized user regardless of their location. 

This was not possible with the previous system," says Gottfried Ludewig, head of the international healthcare business at Telekom subsidiary T-Systems, highlighting an advantage of TrialComplete Early Phase. "Additionally, the solution, developed as Software-as-a-Service, eliminates the need for expensive local installations and allows for easy integration of external sites and partners as well as internal databases."

Secure Data Storage

Study data is stored, among other locations, in the regional high-security data centers of the Open Telekom Cloud. These data centers are ISO/IEC 27001 certified and comply with the strict requirements of the General Data Protection Regulation (GDPR).

"We ensure that the data is secure, always available, and protected against cyberattacks with over 2,400 cybersecurity specialists. We guarantee that the particularly sensitive data of study participants will not fall into unauthorized hands," saysLudewig. Even in the event of a data center outage, the data remains available and usable, as it is mirrored and stored in another data center.

Precise Control of Blood Draws and Examinations

TrialComplete Early Phase controls the entire execution process of a study and precisely supports second-by-second blooddraws, examinations, and measurements on the participants while considering all regulatory requirements. TrialComplete EarlyPhase digitizes the processes defined in the study protocol and captures data largely through barcode-supported, monitoredprocess execution and integrated medical devices.

Thanks to a participant database, individuals can be easily and purposefully recruited. In addition, the clinical laboratories aredigitally connected, and sample processing and result collection are centrally managed. Moreover, data can be transmittedelectronically and in compliance with data protection regulations to other locations.

"The system is highly configurable and is continuously developed in co-creation with Telekom, ensuring that we have a future-proof solution for all stakeholders in the coming years while confidently addressing the growing demands on our clinical studies," says Martin Manzoni, head of Technical Services at the Human Pharmacological Center at Boehringer Ingelheim.

 

About Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company operating in human medicine and animal health. As one of the largestinvestors in research and development, the company focuses on developing innovative therapies in areas with significantunmet medical needs. Due to its independence since its founding in 1885, Boehringer takes a long-term perspective andembeds sustainability throughout the entire value chain. More than 53,500 employees serve over 130 markets for a healthier,more sustainable, and equitable future. Learn more at www.boehringer-ingelheim.com.

 

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About Telekom Healthcare Solutions: https://www.telekom-healthcare.com/

 

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