Two of the most important issues for clinical trials are patient safety and the therapeutic efficacy of the pharmaceutical drug being tested. Improper temperature conditions or stability profile during transports or storage can affect investigational product integrity, either making the product less effective or even compromising clinical trial success.
OCEACLINIC™: AN END-TO-END TRACEABILITY MONITORING SOLUTION DEDICATED TO CLINICAL TRIALS
OCEASOFT developed OCEAClinic™ to meet the needs and challenges of stakeholders involved with clinical trials.OCEAClinic™ offering includes:
- Compact autonomous dataloggers integrating Bluetooth®, NFC, LTE, and 2G/3G technologies
- Intuitive OCEAView™ web, PC and mobile applications
- Access to data stored on secure Cloud service
- Full-featured service offering, including integration with your information system or that of your CRO, sensor calibration, training, support and more.
OCEAClinic™ enables temperature end-to-end traceability over the entire logistics chain for clinical trials, both in shipping and storage phases, by enabling you to place an autonomous datalogger directly inside the product box to accurately monitor relevant ambient conditions closely.
The small-footprint modules and advanced features of OCEAClinic™ give you a complete and flexible offering that adapts to the specifics of each environment, whether the shipments are single- or multi-package. The datalogger can be placed on a palette, inside a container with multiple product boxes, or directly inside the product box to monitor.
With OCEASOFT's companion OCEAView™ web, PC, and mobile applications, you can read data wirelessly via Bluetooth® using a smartphone, tablet, or computer. Data is stored on the secure OCEACloud™ platform on the Cloud, or on a different Cloud service via API, offering unlimited access from anywhere in the world so you can analyze your data easily to optimize route planning and take other actions.
OCEASOFT also developed some automation tools to further simplify the operations: the OCEABridge™ wireless connected receiver collects data automatically; and the Loading Bench provides a streamlined process that simplifies programming steps and the mission's monitoring settings.
Download the OCEAClinic™ brochure: http://www.oceasoft.com/files/brochures/201703-OCEAClinic.pdf
QUALITY AND COMPLIANCE
Whether it comes to hardware design and management, software development, customer services or internal processes, compliance has always been a major concern for our company. Our ISO 9001 certification further demonstrates our quality actions. Sensor calibrations are available from the in-house laboratory: ISO/IEC 17025 (COFRAC) accredited, OCEASOFT certified, or NIST-traceable.
All our solutions are designed to help our customers to comply with the strictest standards and regulations such as 21 CFR part 11, Good Manufacturing and Good Distribution Practices Guides, IQ/OQ, and more.
Phone: +33(0)4 99 13 67 30
Fax: +33 (0)4 67 42 84 13