Services

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