Accelerate your clinical trials with targeted management solutions that streamline operations and enhance data integrity.
Adlib streamlines the intake of diverse document types essential for clinical trials, such as informed consent forms, trial protocols, and investigator brochures. This process ensures that all necessary documentation is collected and organized from the initiation of the study, facilitating a comprehensive and accessible document repository for the entire trial duration.
By converting trial-related documents into a uniform format, Adlib enhances the consistency and accessibility of critical information. This standardization supports regulatory compliance, simplifies the audit and inspection process, and ensures that all stakeholders have access to clear and concise trial data.
Adlib leverages advanced technologies to accurately extract vital data points from clinical trial documentation. This precision supports informed decision-making, improves data accuracy, and significantly reduces the manual effort required in data review and analysis, enhancing the overall efficiency of the trial management process.
Adlib's automated document assembly feature efficiently organizes essential trial documentation, including eTMF, in strict compliance with regulatory requirements such as CFR Title 21 Part 11 and Good Clinical Practice (GCP) guidelines. This ensures that all documentation is audit-ready and meets the rigorous standards of regulatory inspections.
Through meticulous validation processes, Adlib ensures the completeness and accuracy of the trial documentation, adhering to all regulatory standards. This critical step minimizes the risk of non-compliance, avoiding potential fines or trial delays, and upholds the integrity of the trial by ensuring that all documentation is accurate and complete.
Adlib prepares and organizes the eTMF and other relevant documentation for final submission to regulatory bodies, ensuring that every document is compliant, accurately formatted, and meticulously organized. This preparation is crucial for the timely approval of manufacturing licenses, avoiding unnecessary delays or rejections due to documentation errors.
Adlib works across your entire organization’s disparate data sources to read and distill all your critical documentation, from any source. It then automatically converts it all into machine-readable and compliant documents of record, and finally, deposits those standardized documents into a central database in submission- and archive-ready formats.
Use these expert insights in your evaluation of document rendering platforms to uncover the complexities of document conversion and determine the key capabilities your ultimate choice must have.
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Adlib Software helps organizations meet compliance and governance requirements by implementing a set of business rules upon ingesting documents across several formats to deliver a “document of record”. These business rules define the creation of a custom header-footer, watermarks and the auto-generation of a table of contents, besides combining multiple formats into a single readable-searchable PDF. The result is an audit ready document that meets compliance and governance requirements. In addition, Adlib Software’s Transform Platform also implements document security and archival features when rendering documents of record to be in compliance with such policies resident within an organization. Finally, it also provides audit trails and reporting capabilities to help organizations track and monitor document activity.
Adlib Software is ideal for industries that generate large volumes of unstructured data that has to be managed to mitigate compliance, operational, audit and regulatory risks. Major industries use that to leverage our capabilities are as follows:
In addition, Adlib Software is also useful for any organization that needs to manage and analyze large amounts of data in various formats.