Clinical Trial Characteristics of Blood Products
There is significant variety in blood constituents among patients, including components like fibrinogen, factor VIII, factor IX, PCC, hepatitis B immune globulin, human immunoglobulin, and CMV immunoglobulin etc. ,but there are often limitations in data collections in hematologically diseased patients, effectively increasing the difficulty of clinical development in this area. Besides this, the requirements for preservation and cold chain transportation (2-8 degrees) and central laboratory compliance are challenging.
Advantages of Tigermed
According to the needs of each individual trial, we carefully analyze the available information and formulate science and risk-based plans to provide our clients with a clear strategy to enable early access and market success. We have a proven track record of providing clinical development services in R&D and facilitating marketing authorization and access for many projects of all the above-mentioned blood products with trial ranging from local to multi-center trials.
For each of the different indications of various types of medication, we have developed complete management processes to guarantee the smooth clinical development of your product. Also, each of our centers has established a well-preserved pathogen bank that is used in clinical trial management projects of corresponding pharmaceutical indications.
The blood products team is managed by 3 project directors and 6 project managers that have an average working experience of 8 years.
Our clinical trial experience includes but not limited to the following indications for blood products:
- Intraoperative and postoperative treatmentof hepatitis B or liver cancer-related liver transplantation
- Hemophilia A
- Hemophilia B
- Primary fibrinogen deficiency
- Secondary fibrinogen deficiency
- Liver-kidney transplantation-associated cytomegalovirus infection
- Idiopathic Thrombocytopenic Purpura (ITP)