DataLabs is the first vendor to implement electronic signatures out-of-the-box guaranteeing signer authenticity and data integrity.
PHILADELPHIA-June 19, 2006-DataLabs, an innovative developer of Internet-based software applications for clinical development, today announced the launch of Site Manager™ 2.0 at the 42nd Annual Drug Information Association (DIA) Meeting. Advanced clinical trial software, Site Manager 2.0 improves the site selection and activation processes as well as overall site satisfaction with easy to use, Web-based site management software. Site Manager 2.0 integrates CoSign®, Algorithmic Research's (ARX's) electronic signature solution, enabling users to sign documents with secure, regulatory compliant, electronic signatures that complete the migration to paperless processes, further streamlining clinical trial efficiency.
Site Manager 2.0 is a communication portal that extends electronic data capture, allowing sponsors, clinical research organizations (CROs), investigator sites and other trial participants to streamline data exchange and entry, document processing and data management. With Site Manager 2.0, sponsors or CROs can quickly identify and initiate investigator sites and then monitor and administer the site during the course of the trial. Built on Microsoft's SharePoint technology, Site Manager 2.0 meets CDISC ODM standards and complies with FDA 21 CFR Part 11.
DataLabs will be at booth #1829 at the DIA Annual Conference.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.