services - caropharmed

services

PRE-CLINICAL STUDIES

first stage

● Performing studies

Second stage

● Reporting

CLINICAL STUDIES

Phases I, II, III, and IV
Providing Gantt chart and budget estimation
Designing
Obtaining clinical trial authorization and other permission (EC, CTA,...)
Conducting
Reporting
Holding and managing DSMB and other meeting
Monitoring and Auditing
Data management and analysis
Interim and final report
Article writing

EDUCATION

Requirements for clinical studies

Pharmacovigilance requirements

How to prepare module 4 and 5

PHARMACOVIGILANCE

Setting up the pharmacovigilance system

Designing pharmacovigilance studies

Performing pharmacovigilance studies

Preparing pharmacovigilance studies report

Preparing common technical documents of drug

Preparing PSUR, PMS reports

PREPARING COMMON TECHNICAL DOCUMENTS OF DRUG

Preparing module 4 (preclinical studies) of drugs

Preparing module 5 (clinical studies) of drugs

SUPPORTING THE PATIENTS

Setting up a patient support unit in the company

Setting up a patient support unit in medical centers

Compilation of patient education documents

Following up the patients

EXPORT

Preparing the documents according to the requirements of the destination Country