In clinical studies, assessing and managing risks, as well as establishing areas of uncertainty that contribute to risk, are critical to a company’s decision making processes. Many business units within pharmaceutical, biotechnology and clinical research organizations must comply with federal regulations concerning their processes and computerized systems. One of the most challenging processes throughout clinical studies is the creation and management of assay plans and tracking assay inventory.
The primary goal of Novatek’s Clinical Assay Management Software is to assist principal investigators and clinical study teams in improving the efficiency and effectiveness of their clinical research.
Novatek’s Clinical Assay Management software is a unique information management application that provides a consistent approach to the collection, management and integrity of clinical research study data. Novatek’s Clinical Assay Management software tracks and manages all sample data throughout its whole analytical process and ensures a single verifiable version for all clinical and analytical data sets.
Novatek’s Clinical Assay Management software `helps organizations manage their studies based on a particular product that is being developed. In addition, this application will give clinical studies the structure that is required to ensure all related steps are executed in a timely manner.
Novatek’s Clinical Assay Management software also includes a full document management solution that enables departments to effectively share content and assay data management to meet and facilitate compliance within different complex regulatory environments.
Selecting the right solution can favorably impact an organizations drug development, timelines, and decision-making processes. The ability of tracking all assay samples and their related results throughout their whole analytical lifecycle is the key feature in Novatek’s Clinical Assay Management software application.
Novatek’s Clinical Assay Management software helps organizations capture every event throughout a clinical assay study while maintaining compliance and improving overall efficiency within its laboratory studies.
FEATURES & FUNCTIONS
- Tracks sample shipment receipt, storage, & distribution
- Tracks sample plate & tray management
- Records and documents sample freeze-thaw tracking & freezer manager (chamber) information
- Includes a full document management system
- Creates comprehensive reporting & statistical analysis
- Provides systematic & auditable processes for handling clinical data
- Streamlines the clinical assay management process
- Improves presentation & documentation for anticipated FDA inspections
- Allows for higher control & automated data management
- Enables compliance within complex regulatory environments
- Reduces regulatory compliance costs
- Integrates with other Novatek product modules