Clinical trial is a secondary objectives of business in pharma companies which expense to much money, spending much time and also hiring staffs that may not use all the time, but outsourcing to our CRA can be part of that solution.
Clinical Research Associate (CRAs) of Prodia the CRO are GCP certified. Dedicated CRAs will provide “good, high quality and confidential data of your clinical studies” and producegood studies under a variety of circumstances with investigators and protocols of varying quality, as we understand that poor study monitoring is probably the largest single contributor to inferior study quality
We have our own monitoring strategy to make your trial conduct compliance to GCP, SOPs, protocol through good service in :
A. Checking protocol adherence
Checking protocol adherence is make sure that the trial’s conduct compliance with the protocol beside EC, regulatory, SOPs and GCP. Our CRAs will check the following items but are not limited to:
•Subject randomization
•Subject eligibility
•Protocol activities
•Visit schedule
•Drug dispensing
•Others
B.Case Report Form review
We concern about completeness and accuracy of your CRF as we review each page of it in details.
C. Source documents review
Verification of CRF Data with Source Documents including the patient chart, laboratory repots, and other supporting documents for completeness and consistency
D.Inform consent review
Our CRAs concerns about compliance, consistency, and quality inform consents either in pre study, during or post study,we also concerns about any trial/protocol amendments that related to inform consents.
E.Serious adverse event review
Monitoring safety during clinical trial is one of the most important tasks for our CRA. Our services include:
*identify and report significant adverse events to appropriatestaff
* ensure that safety reporting requirements have been met (e.g., IRB/IECsafetyreports, reconciliation of SAE reports with CRFs)
F.Investigational product review
Our CRAs ensure that your investigational product is being used properly according to protocol and the randomization scheme to subjects.
We also ensure about the storage of your investigational products
G.Queries and error correction
Our service in CRF Query Management for any protocol deviation during your trial.
H.Review of laboratory samples
Our CRAs ensure blood or other samples are to be collected
I.Study document file review
Our CRAs ensure that copies of all pertinent documents are available and filed. We make sure completeness investigator’s and sponsor’s study document file.
J.Monitoring visit report
Our CRAs summarize in details about their activities during the visit including any problems at the investigative site, what was done to solve them, or to make recommendations of action items for the next visit.
SERVICES 
