Drug and Biologics Temperature Monitoring (Cold Chain)

Brochure

Tri-Fold Brochure

Study Management Temp Monitoring

Cold Chain Management Ad

Drug and Biologics Temperature Monitoring
(Cold Chain)

YOUR FIRST CHOICE FOR QUALITY, COST-EFFECTIVE DRUG & BIOLOGICS TEMPERATURE MONITORING

During clinical studies, monitoring of temperature sensitive drug and biologics is imperative for safety and efficacy. Our professional Study Analysts will work with your study team and clinical sites to ensure that product is received, stored, and transferred at appropriate temperatures. We will perform an initial evaluation of site cold chain capabilities, as well as provide hands-on training and guidance to facilitate long term compliance.

Drugs and Biologics can require continuous temperature monitoring from manufacture to subject administration in order to document safety and efficacy. BMA will manage continuous temperature monitoring to ensure that the cold chain is adequately maintained

STUDY COLD CHAIN DEVELOPMENT
Proactive Planning

• Development of study-level procedures
• Creation of temperature monitoring documentation
• Delivery of customized training to sponsor team and monitoring staff
• Selection of temperature monitoring equipment based on sponsor provided specifications

COLD CHAIN CAPACITY
Mitigating Risk

• Assessment of site cold chain storage capability
• Identification of resolutions to impediments in appropriate transport and storage of temperature sensitive drugs and biologics
• Evaluation of existing site temperature monitoring systems to ensure compliance with sponsor specifications
• Provide training to site staff on cold chain practices

CONTINUOUS COLD CHAIN MONITORING
Quality Management

• Ongoing site monitoring for cold chain compliance
• Dissemination of study specific temperature monitoring devices
• Facilitate transport and storage deviation reporting
• Identify and enable fulfillment of corrective action plans

CUSTOMIZABLE SERVICES
Tailored Partnership

• Audit-ready documentation prepared and maintained
• Employ the use of sponsor and distributor’s randomization and distribution systems
• Certified field monitors to conduct initiation, interim & closeout visits
• Negotiation of site specific cold chain budgets
• Maintenance of sponsor systems & databases