CLINICAL TRIAL MANAGEMENT
- Support feasibility request from Sponsors and initial consulting services to Principal Investigators (PI) who are keen to do Investigator Initiated Trials (IIT)
- Perform budgeting and costing preparation/negotiation
- Provide administrative support, including finance, monthly study tracking log monitoring and billing
- Assist with patient recruitment
- Supplement patient recruitment with in-house healthy volunteer database
- Assist with applications for submission to the ethics and regulatory authority (if applicable) for approval for the conduct of a clinical trial/research
- Ensure timely proper source documentation, Case Report Form (CRF) completion and maintenance of Investigator Site File (ISF)
- Transcribe data from paper CRF to electronic CRF (if required by sponsor / PI)
STUDY COORDINATOR SERVICE
- CITI certified and ICH GCP trained
- BCLS & AED and Code Blue trained
EQUIPMENT RENTAL
- Centrifuges (with temperature control setting capability)
- Biosafety cabinet
- Vital signs monitors
- Infusion / Syringe pumps
- ECG machines
- Digital weighing scale
- Adjustable volume pipettes
BIOSTATISTICS SERVICE
- Protocol design consultation
- Study level interim / Final data analysis
- Randomization Plan and code generation
- Sample size calculation
PHLEBOTOMY SERVICE
- Trained phlebotomist to perform venipuncture and collection of blood samples.
ON-SITE STORAGE OF STUDY DOCUMENTS
- Secured and password protected rooms
INVESTIGATIONAL PRODUCT (IP) MANAGEMENT
- IP storage
- IP Accountability
- IP Administration
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