Our Services

Tasks before the study initiation

Feasibility

Completing with the PI and transfer to the Sponsor in time

Study set-up documents

Collection the needed documents and transfer them to the Sponsor

Ethics Committees

Information about the trial

Training / Investigators Meeting

Participation and performance

Source document template

Performance

Trial related trainings (eCRF, SAE etc.) Performance

Tasks during the study

Informed Consent

Hand out, Collection, checking and storage

Inclusion and exclusion criteria

Checking

Patient’s demography

Data and document collection, checking

Medical History

Data and document collection, checking

Physical Examination

Data and document collection, checking

Quality of Life questionnaire

Data collection, checking

12 lead ECG

Data and document collection, checking 

Randomization

Performance

Study drug administration

Data and document collection, checking

Study drug accountability

Performance

Adverse Event / Serious Adverse Event procedures

Performance and checking with PI, SI

Prior / concomitant / post medication

Data and document collection

Data clarification

Performance and checking with PI, SI

Blood sampling

Data and document collection, checking

CRF/eCRF completion Performance
Site File maintenance Performance
Site and trial coordination Performance
Trial related administration Performance
Study report to the Sponsor, CRO, Site Performance


* PI’s delegation is needed that the Clinical Research Coordinator can do the following tasks.

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