IVD Devices Contract Research Organization (CRO) Partnership

Project Description

FDA GMP Contract Research Organization (CRO) needed for comparative study for in-vitro diagnostic (IVD) devices. We manage this study on behalf of a major sponsor, details shared below.

If partnering is of interest to you, please let me know, and we can set up a meeting to discuss the budget & details. Let us know if you can support this request.

Requirements:
- Testing samples with the standard lab equipment.
- Running the same samples in the sponsor provided testing tool.
- The device is very small, 8 cms. The width is about 3 cm.
- IVD testing is done of these samples on a device.
- The test kits will be sent by the sponsor.
- Providing the data outcomes from both the testing

Disease Indication:
- HBsAg
- HCV
- CRP
- HIV

Sample type:
- Serum, blood plasma, whole blood, fingertips from each patient.
- 15-20 ml of whole blood, 2 K2eDTA tube which is about 10 ml each
- The volume of serum and plasma for one test is about 5 ml
- Finger blood- 0.5 ml

Sample size:
- HBsAg- 1980 samples
- HCV- 1980 samples
- PRC- 400 samples
- HIV- >800 samples

Clinical Data Required:
- Age
- Sex
- Test reports