Advertisement AtoZ-CRO Services - Pharmaceutical Business review

Advertisement

Pharmaceutical Business review is using cookies

ContinueLearn More
Close
More info about AtoZ-CRO

AtoZ-CRO Services

AtoZ-CRO

AtoZ-CRO offers the following services:

CLINICAL STUDIES PHASE I-V

  • Planning of clinical studies
  • Generating Study Protocol
  • Design and implementation of Case Report Forms (CRFs)
  • Processing of applications for Authorities and Ethical permissions

MONITORING

  • Recruitment and assessment of Study centres
  • Initiation of Study centres
  • Training of Investigators and their staff
  • Monitoring of Study centres
  • Source Data Verification (SDV)
  • Checking of CRFs for Completeness and Correctness
  • Maintaining communication between Investigators and Sponsor
  • Coordination of Investigational Product (IMP) Flow
  • Status Reports

PHARMACOVIGILANCE SERVICES

  • Collecting and analyzing of (Serious) Adverse Events
  • SAE database with the possibility of E2B reporting to European and US Regulatory Authorities
  • Reporting of SUSARs
  • Training of Investigators concerning (S)AE documentation and reporting
  • QPPV on a contract basis

BIOMETRY

  • Generation of Data Management Plan (DMP)
  • Data Processing
  • Preparation of Biometrical Report (ICH 09)

COORDINATING of IITs

MEDICAL WRITING

  • Preparation of Final Study Report (ICH E3)

MEDICAL TRANSLATIONS

EPIDEMIOLOGY STUDIES

PROFESSIONAL STAFFING

TRAININGS & SEMINARS

  • ICH-GCP Basic & Refresher Training for Investigators, Study Nurses and CRAs
  • Basic Monitoring Training
  • Communication in Clinical Trials Seminar
Quick Contact AtoZ-CRO Services