- Boehringer Ingelheim Relies on the TrialComplete Early Phase (TCEP)
- TCEP is an eSource and automation platform for Early Phase trials for documentation and collecting data compliant to data security and GXP standards
- Data is collected quickly, effectively, and securely
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 collect and process data quickly, effectively, and securely in our Phase I studies. Paper documentation is largely a thing of the past, and the high availability of data in electronic form supports the safety of participants in our studies and accelerates the execution and 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, the fundamental properties of a new drug, including its tolerability and safety, are thoroughly examined to determine its suitability for 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 in Biberach.
"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
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," says Ludewig. 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 blood draws, examinations, and measurements on the participants while considering all regulatory requirements. TrialComplete Early Phase digitizes the processes defined in the study protocol and captures data largely through barcode-supported, monitored process execution and integrated medical devices.
Thanks to a participant database, individuals can be easily and purposefully recruited. In addition, the clinical laboratories are digitally connected, and sample processing and result collection are centrally managed. Moreover, data can be transmitted electronically and in compliance with data protection regulations to other locations.
"The system is highly configurable and Telekom is continuously deploying improvements, 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 BoehringerBoehringer Ingelheim is a biopharmaceutical company operating in human medicine and animal health. As one of the largest investors in research and development, the company focuses on developing innovative therapies in areas with significant unmet medical needs. Due to its independence since its founding in 1885, Boehringer takes a long-term perspective and embeds 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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