Sponsors / CRO Services

Haxon provides services in all related spheres to support our clients’ Clinical trial processes. The services are customized to our clients’ requirements. We look to enable our clients to perform to their best potential. We help them to streamline their activities and extend their geographic coverage in order to capitalize on their products as swiftly and effectively as possible in the marketplace.

CRO Services

  • Efficient site selection after a reliable feasibility data analysis
  • Short turnaround time with feasibilities
  • "Organizational Structure" offers Sponsor and CRO clients immediate

access to several pre-qualified investigators in all therapeutic segments.

  • Efficient short listing of prospective Investigators from our database
  • Work with sites for Pre-initiation and prepare them for trial-related activities
  • Evaluation of sites based on the patient pool, investigator's area of expertise and connectivity to the site.
  • Network of the top enrolling sites nationwide on multiple studies under their inherent merits
  • Sites well equipped with infrastructure and logistics required for clinical trials
  • Pre-study set up of the site
  • Clinical Trial Agreements as per projected study budget and review
  • Infrastructure provisioning
  • Procuring pre-study essential documents
  • Conduct of Investigators' Meetings
  • IEC/IRB submissions and follow up for timely acknowledgements and approvals
  • Documentation procedures, such as Trial Master File Management, Central
  • Investigator File and Investigator Site File
  • Training on IP handling, lab sample handling procedures, ECG, etc.
  • Efficient coordination of the logistics
  • On-site developmental briefing of Investigator and the research team
  • Streamlined and expeditious start-up and completion of studies on schedule

Maintenance of CRFs, Informed Consent Forms (ICF) and study logs

  • Timely resolution of queries which help the sites to generate clean & legible data
    Drug accountability, preparation and dispensing as per the study protocol requirements.
  • Excellence in on site coordination and monitoring of Phase II, III, and IV clinical trials
  • Database at site as well as centrally (at headquarters), serves as a quick, efficient and effective tool to deliver accurate, precise feasibility analysis

 

  • Setting up Primary and Secondary Objectives of Clinical Trial.
  • Defining Key Inclusion and Exclusion Criteria of Clinical Trial.
  • Case Record Forms (CRFs) Designing.
  • Clinical Trial Steering Committee Charter / SOP.
  • Clinical Trial Protocol Designing.
  • Clinical Evaluation Plan (CEP) Designing.