Services

Regulatory

Services In Unite Clinical Research Consortium we are to make sure that all regulatory requirement is in full compliance and proper completion prior to submission to the IRB. These processes are handled and completed adequately by our teams prior to the initiation of each protocol. Therefore, we follow and comply in the conduct of any clinical trial with all local and international regulation such as the FDA 21 Code Federal Regulation, GCP of the ICH Guidelines, and the EMA directives, if applicable.

 

Unite Clinical Research Consortium servicing as a central entity, will allow our pharmaceutical/CRO clients to do site identification, feasibility and study start up-implementation in a timely manner. As a result, the following services are available to all of our clients:

  • Feasibility Studies

  • Investigator Selection

  • Conduct of Phase I-IV Studies

  • Central Management of Clinical Trials

  • Contract/Budget Management

  • Site Management

  • Clinical research personnel trained on ICH/GCP

  • Patient Recruitment Strategies

  • Quality Assurance/Quality Control Support

     

Clinical Trials Administrative Activities

Clinical Trials Management and Operations (Phase II – IV)

Our professional team will implement process, drive performance, and leverage the talent of the medical research team that increase performance and productivity. Additionally, we create global clinical evidence strategies that ensure accelerated market access worldwide.
    I. Identify Sites
    • Send request
    • CDA
    • Study Feasibility Questionnaire
    II. Initiate Sites
    • Conduct PSV
    • Initiate CTA
    • Negotiate Contracts-Site Initiation Visit
    III. Activate Sites
    • Conduct the Investigator Meeting
    • Prepare Regulatory documents
    • Wrap-up

Clinical Trials Start-up Study Site and Investigator Development

  • Educate and Train physicians and professionals on the process for conducting clinical trials.
  • Learn and thoroughly understand government and industry regulations.
  • Establish the needed infrastructure to accommodate the conduct of clinical trials including research team staffing requirements.
  • Perform search activities for clinical trials including online database search for potent investigators.
  • Identify then register the physician and/or study site, and complete all required forms such as IND, CDA, curriculum vitae PI and Sub-PI, Form 1572, IDB, IFD statement, IRB and IEC approval letter and roster, laboratory certifications and normal ranges; and the PI financial disclosure statement.
  • Prepare the potential study site for the Pre-Study Visit (PSV) by the sponsor.
  • Receive the IRB or IEC approval, contract, and all essential documents to ensure proper completion.
  • Support Patient Recruitment and retention.
  • Manage CRO, CRA, and Research Assistance activities.
  • Marketing and Business Development.