The Nutrasource clinical trial facility houses a dedicated pharmacy. 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.
With knowledge of labelling requirements for foods, dietary supplements/natural health products, medical foods and pharmaceuticals, our staff are able to prepare study product labels for clinical trial materials compliant with the jurisdiction in which the study will be conducted.
Nutrasource has the flexibility to design and provide label templates consistent with regulatory requirements (including bilingual labels required for Canada) to the manufacturer, or to provide staff not involved in the conduct of the clinical research trial to label study product in-house. Nutrasource also offers Sponsors options for primary and secondary packaging.
Our expertise in packaging, design and supply management includes:
- Robust 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; and
- Stability programs.
Nutrasource works with our partnering Sponsors to provide solutions for all phases of clinical research, ranging 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 and ensure the best possible clinical trial experience for both the investigator and the patient, while ensuring the integrity of the clinical trial is maintained.
Looking for more information on our pharmacy? Contact a member of our team today or email us directly at firstname.lastname@example.org. You may also request a customized quote and we will contact you with details within two business days.