Medical specialist services

Tender description

The University of Birmingham have a strong healthcare product development pathway for pharmaceuticals, medical devices and diagnostics and their translation into clinical trials. The healthcare technologies Institute currently hosts a pipeline of products designed to prevent scarring in range of tissues around the body and aim to take through phase 1 and 2 clinical trials. Key to these projects is the establishment of pre-clinical safety as part of the regulatory application process for clinical trial. We require the services of a pre-clinical safety Contract Research Organisation (CRO) to execute a set of in vivo studies on a skin dressing product containing a biologic drug. The University of Birmingham have a strong healthcare product development pathway for pharmaceuticals, medical devices and diagnostics and their translation into clinical trials. The healthcare technologies Institute currently hosts a pipeline of products designed to prevent scarring in range of tissues around the body and aim to take through phase 1 and 2 clinical trials. Key to these projects is the establishment of pre-clinical safety as part of the regulatory application process for clinical trial. We require the services of a pre-clinical safety Contract Research Organisation (CRO) to execute a set of in vivo studies on a skin dressing product containing a biologic drug. Critically, we require these services to commence within the next 2 months and issue draft reports within 6 months of start of studies. Services include but not limited to: — method development of PK Assay Elisa method, — validation of a PK assay Elisa method for determination of TA (OECD, GLP), — a repeat dose dermal pharmacokinetics study, — a 28-day dermal toxicity study with a 14-day recovery. The University of Birmingham engages with numerous CROs with the capability to design, execute and report such studies for a range of other projects in our pipeline. However, this particular package of work is very time critical. We require a package of work to bridge a knowledge gap at the request of the UK’s competent authority on pharmaceuticals, the Medicines and Healthcare Products Regulatory Agency (MHRA). The data required must form part of our final Clinical Trial Application (CTA) submission planned in 2019. The University intends to contract these activities to ITR Laboratories Canada Inc. Namely, they; — have a demonstrated track record of designing, executing, and reporting of pre-clinical safety studies for topical skin products, — can meet the required timelines on commissioning and starting the pre-clinical studies. ITR Laboratories Canada Inc. has built a reputation over the last 25 years for toxicology testing by providing access to specialist testing services for the biotechnology and pharmaceutical industries in North America, Europe and beyond. Furthermore, ITR is a small-medium scale CRO enabling it to operate with short lead times, quick adaptability, price point flexibility and timeliness of delivery.