Our Services

 Home / Our Services /Clinical Trial Management

Excellence in Execution

Clinical trials require the use of human subjects and can severely impact the safety and well-being of the participating subjects. Success or failure of clinical trials can also severely impact large amounts of capital. For those performing the trial, the proper management of clinical trials is crucial.

The clinical trial execution process at Ethicare involves coordinating people and resources, as well as integrating and performing all study-specific and needed activities in accordance with the study protocol and the project management plan.

Ethicare’s Clinical Trial Management services include:

  • Setting up study-specific procedures and documents, such as:

  •  Feasibility questionnaires
  •  Site assessment and identification plan
  •  Monitoring plan
  •  Patient information leaflet and informed consent documents
  •  Patient recruitment plan
  •  Patient retention strategy
  •  Trial master file (TMF)
  •  Investigator Site Master File
  •  Contract negotiation and implementation
  •  Grant management

  • Selection and coordination of:

  • Central laboratories
  • Investigational medicinal product logistics
  • Data Monitoring Committee

Training for study specific-procedures and underlying regulatory requirements to all involved stakeholders.

Coordination of all study-related activities in all participating sites and between all involved stakeholders.

Organization of meetings, e.g. investigator meetings.

Management of Vendors and External Partners

Global clinical trials usually involve many different parties and vendors. The Ethicare Clinical Trial Management team provides a pivotal contact to all involved parties, such as:

  •  Central laboratory
  •  Interactive Voice Record Systems (IVRS)
  •  Investigational medicinal product and other material providers and logistic companies
  • Data Monitoring Committees


Ethicare’s Clinical Trial Management team can organize meetings for your trial, such as:

  •  Investigator meetings
  •  Monitor meetings
  •  Data Monitoring Committee meetings

    We will reconcile all needed presentations and material for each meeting. Most of the presentations will be conducted by our experienced team members with utmost professionalism.

Trial Master File

Regulations require a trial master file (TMF) to be created and maintained for a clinical trial. Ethicare compiles and files all trial essential documents and information in a coherent format to enable your own ease of access and ready availability for audits and regulatory inspections. TMFs can be created and maintained as paper only.

Ethicare’s Clinical Trial Management team tracks and reviews each document and can provide clinical monitors and other parties with comprehensive reports on outstanding documents, inconsistencies between the documents and any other helpful information.

At project closure, the TMF will be transferred to your preferred final archiving location accompanied by a complete and comprehensive table of contents and inventory of all documents and binders to facilitate future access.

Contract and Management

Ethicare has good experience with all types of study-related contracts in various trial types, such as:

  •  Investigator / hospital / sponsor clinical trial agreement
  •  General practitioner (GP) / sponsor clinical trial agreement
  •  Hospital pharmacy / sponsor clinical trial agreement
  •  Central laboratory / sponsor / CRO clinical trial agreement
  •  Local laboratory / sponsor / CRO clinical trial agreement
  •  Other vendors clinical trial agreements
  •  Patient reimbursement agreements

    In cooperation with our Ethicare Finance department, we will arrange and carry out all clinical trial grant management work and money flow according to the payment schedule agreed in each individual contract.

Logistic (IMP and Other Material)

The Clinical Trial Management team sets up all needed processes around supply management, including:

  •  Design of logistic processes and responsibilities within the workflow
  •  Selection of suitable vendors for printing, packaging labeling and shipment
  •  Warehouse management
  •  Identification of any import and export requirements
  •  Monitoring and green-light process for investigational medicinal product (IMP) release for each investigational site
  •  Collection and destruction of unused materials