Trial Management

Conducting research, domestic and offshore, requires partners that can ensure trials meet both local obligations and FDA standards. CiPharma’s experience spanning twenty years allows your company to leverage our background in providing global and region specific support to sponsors, research sites or internal organizational units.

CiPharma provide the capabilities and expertise required to manage the trial at the required time, location, specialism and scale you want , large or small.

Management and Regulatory Experience

With regulatory and clinical research experience, our site management teams have the expertise necessary to navigate the complex operating and regulatory environments of initiatives that cross multiple borders. We are versed in:

  • Placing and managing full-time coordinators trained in ICH-GCP, schedule Y and local regulatory requirements
  • Modern technology infrastructures and experience with EDC and IVRS
  • Rapid turn-around for regulatory submission, including Ministry of Health (MOH) and IND approval

Your clinical programs benefit from a flexible support model designed to serve and compliment  the needs of sponsors, services offered by global CROs or your own in-house research sites. Our client and site centric approach helps ensure on-time enrollment, strong retention, and quality data with FDA approval throughout a comprehensive clinical trial and site management process:

Pre-Trial

  • Site identification, evaluation and selection
  • Principal Investigator (PI) selection and training
  • Study feasibility assessment
  • Coordinating translation of essential documents
  • Identifying couriers and support service vendors
  • Regulatory submission and rapid approval
  • Obtaining import/export licenses for Clinical Trial Materials (CTM) and samples
  • IRB submission and rapid approval
  • Site set up in accordance with trial protocol
  • Document collection and management
  • Creation of source document template
  • Preparation of site for Site Initiation Visit (SIV)
  • Patient pre-screening for chronic disease trials
  • During Trial

  • Informed Consent, screening and enrollment assistance
  • Patient retention and compliance support
  • Managing CTM distribution and logistics
  • Coordinating central lab logistics & sample flow
  • Coordinating monitoring & audit visits
  • Coordinating subject reimbursements
  • Maintaining and updating trial master file
  • Coordinating Serious Adverse Events (SAE)
  • Data management and performance tracking
  • Post-Trial

  • Coordinating close out visits
  • Query resolution and document archiving
  • Final reconciliation and return of CTM
  • Final report to ethics committee (EC)
  • Settlement of all payouts