Clinical compliance services on SOP, GCP, CRF and project management.
Clinical trial monitoring services,multi-centre clinical trial study coordination.
Study sitecoordinator services,study nurse services.
SOP development.
Introduce procedures to new staff
Provide training on clinical research, ICH-GCP, SOP, CRF.
Revision of protocols and assistance in CRF development
Set up of study manuals and logistic procedures.
Clinical trial monitoring in multinational, multi-centre studies across Europe.
Phase III, IIIb and IV studies.
Co-ordination and supervision of monitors.
Training of investigators.
Consultancy
Project management.
Provide training on ICH-GCP, SOP, CRF for investigators.
Study site data coordinator in Phase II, III, clinical trials
Study nurse in Phase II, III, clinical trials
Data review and data entry of registry studies.
Training of a new study nurses.
Provide training on ICH-GCP, SOP, CRF for clinical site personnel.
Trainings & Qualificationsmore informationWe are trained and qualified in clinical trial monitoring, and comply with sponsor/study specific trainings on the study projects.
Clinical Trial Protocol.
Design of the Case report Form.
Implementing and monitoring clinical trials in Europe to Good Clinical Practice.
Clinical trial archiving.
QA - a monitor's perspective.
ICH Guidelines for Good Clinical Practice - Introduction to Clinical Research.
Drug Safety Reporting.
Quality Assurance for Auditors and CRA's.
Product complaint awareness.
Phase-forward training.
CTMS electronic system.
GCP training certificates from different pharmaceutical companies.