Clinical compliance services on SOP, GCP, CRF and project management.
Clinical trial monitoring services, multi-centre clinical trial study coordination.
Study site coordinator 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.
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.
- IATA certificate.