The clock was ticking for a top pharmaceutical company’s vaccine team. After a year of a compressed vaccine development timeline for a life-saving vaccine that held the key to solving a global public health crisis, the Global Vice President of Vaccines at a top pharmaceutical company came to Adlib in a panic.
With hours to go before the final step on their emergency authorization application for the U.S. Food & Drug Administration (FDA), the system crashed. And crashed again. The entire approval submission was in jeopardy.
Transform dark and unstructured data into regulatory compliant documents.
Avoid documentation errors, simplify submission processes, and decrease rejection rates.
Reduce the time and effort needed to maintain ISF files and prepare them for inspection.
Streamline documentation throughout deal lifecycles and ensure regulatory compliance.
Automate error-prone, time-consuming, manual documentation processes.
Automate tasks and reduce manual efforts needed to manage TMF and eCTD documentation.
Create standardized documents to improve data sharing throughout the enterprise.
Improve quality planning, quality control, and quality assurance documentation processes.
Reliable integration with eTMF, RIM, QLM and other software systems.
Assemble and maintain critical data within a centralized and accessible document repository.
Reduce IT budgets and technology footprints via integration with existing tech-stacks.
Standardize unstructured files to create searchable, analytics-ready documents.
and ingest trial and regulatory documentation from any source.
from unsearchable formats into machine-readable and FDA-compliant PDFs.
and assemble multiple files into cohesive / digitally-tagged documents.
documentation by adding headers, footers, watermarks, and tables of contents.
and save files into user-specified folders for downstream processing.