Security Analysis
Our security analysis is based on ISO27001 with its round about 100 controls of Annex A, but doesn't stop there. We have 21 CFR Part 11, the Guideline on computerized systems and electronic data in clinical trials, and other regulations in mind when we analyze the data flow and data governance in your trials.
GAP-Analysis
Based on our security analysis, we do not only identify the gaps, but can recommend strategies and actions to mitigate your individual risks with measures. Our recommendations will be fitting to your company – small or large, sponsor or service provider.
Project Definition
Based on a GAP-Assessment or other input wen can help you to define the project. Furthermore, we can assist your IT and clinical trial strategy, your quality management system, and your IT-environment and IT security approach can be taken into consideration. As data integrity
Project Support
If you need a project manager or consulting in your IT security project just contact us and we will provide you with support fitting to your needs.
We are the right partners leading your project, providing consultancy and successfully accomplishing the pre-defined project goals resulting from the GAP-analysis.
Collaboration Combines Expertise
elderbrook consulting
We provide our services to the pharmaceutical and medical device industry on a global scale. We target quality services for electronic solutions within the frame of clinical development. With our focus on compliance of IT systems in clinical development we are well equipped to perform specific IT security assessments in clinical operations.
Main Analytics
Main Analytics offers high-quality services to clinical trial sponsors: world-leading pharmaceutical companies, innovative biotechs, and research institutes. Their team supports diverse tasks in the field of drug development and the analysis and reporting of clinical studies – from preclinical phase IV, and in various indications. They also support drug approval processes at global regulatory agencies. Furthermore, they offer consulting and auditing for information security and management systems.
Main Analytics builds on latest technologies and team spirit. Founded in 2019 as an employee-owned company, they are located in two German offices: the headquarters in Sulzbach close to Frankfurt/Main and their branch office in Marburg/Lahn.