Clinilabs Drug Development Corporation employs state-of-the-art systems and resources in its optimal management of clinical development projects. These systems live within the space of cybersecure core data centers, under the scrutiny of comprehensive quality control and assurance systems and advanced medical technologies. The core technology center utilizes an array of security equipment, techniques and procedures to control, monitor and record access to patient and customer information. The company’s in-house data management team handles EDC and digital integrations allowing new technologies, such as wearables, to seamlessly advance development programs. Clinilabs uses validated technology systems including artificial intelligence (AI), virtual trials and our proprietary data management and transfer platforms, described in detail below, to meet customers’ objectives in a high-quality, timely and cost-efficient manner.
Clinical InSite™ – Electronic Document Management Tool
Clinical InSite is an electronic document and data management tool that holds clinical trial information in a validated, audit-trailed environment. The system allows multiple users to collaborate by posting, viewing, and editing electronic document and data files of any kind. It is ideal for the management of documents such as protocols, protocol amendments, study communications, regulatory documents, and a host of other files associated with a clinical trial. The system also allows the secure transfer, management, and vault storage of data files, including large files.
File sharing is controlled through permission-based access. Audit trails continuously record user identity, edits, content, and timestamps for all document or data files that are posted or changed. Clinical InSite:
- Improves the speed and ease with which clinical trial files are handled
- Streamlines information exchange, and reduces the administrative costs associated with file management in a clinical trial
- Imposes filing conventions for clinical trial information, so that all files are maintained in a standardized way.
- Obtains data and metadata reports
- Facilitates remote monitoring of clinical trial documents collected at investigator sites.
Clinvia™ – Secure Electronic Data Transfer
Clinvia integrates seamlessly into user environments, enabling the movement of sensitive data with a simple, intuitive application. Users identify and select files much in the same way they usually select email attachments. One or more files may be selected for transfer at the same time, and users may opt to send files immediately or at a later, scheduled time. Once the process is initiated, files are encrypted at the user end, transmitted through a secure pipe, and decrypted in our core technology center. The application is designed to provide secure, compliant file transfers that ensure data integrity and confidentiality.
Users (and sponsors) are able to access information regarding file labels, file transfer time, transfer duration, and the time that transfer is complete. The system also allows users to be queried regarding file data specifics.
Drugs don’t work in patients who don’t take them.
– C. Everett Koop, MD
We empower study participants through informed decisions regarding study participation.
Clinilabs offers a full range of Phase I, II and III clinical development services.