Nutrasource’s on-site clinical trials facility houses a dedicated pharmacy to store your investigational product under the appropriate conditions and security. The pharmacy has restricted access and electronic temperature data logging every minute to provide detailed records of study product storage conditions for the duration of the project and until destruction or return to the Sponsor.
With knowledge of label requirements for foods, dietary supplements/natural health products, medical foods, and pharmaceuticals, our team can prepare study product labels for clinical trial materials compliant with the jurisdiction where the study will be conducted.
Nutrasource provides Sponsors with solutions for all phases of clinical research, from bioavailability and pilot studies through pivotal clinical trials. From sourcing bottles and blister packs to kitting, our team is dedicated to meet individual study requirements to guarantee the best possible clinical trial experience for both the investigator and the patient – all while maintaining study integrity.
We have the flexibility to design and provide label templates consistent with regulatory requirements (including bilingual labels required for Canada) to the manufacturer or to staff not involved in the clinical trial for study product labelling in-house. Nutrasource also offers Sponsors options for primary and secondary packaging.
Our packaging, design, and supply management capabilities for clinical trials include:
- Detailed documentation including temperature records, accountability records, shipping and receiving verification, reconciliation, and destruction records
- Generation of randomization codes and code-breaking strategies
- Procurement of comparator products, rescue medications, and placebos
- Stability testing programs
Learn how we can help you effectively store and manage your investigational product during a study.