OTHER SERVICES
Gregmed's expertise and resources make us a real partner for you and allow us to meet Sponsor's clinical needs executed in a highest quality way.
Our key services include:
PHASE I - IIIB STUDIES:
Gregmed offers to file and archive the study documentation that serve to demonstrate the compliance of the investigator, sponsor and monitor the standards of GCP and with applicable regulatory requirements in an organised way that will facilitate management of the clinical trial, audit and inspection.
We offer:
Gregmed's expertise and resources make us a real partner for you and allow us to meet Sponsor's clinical needs executed in a highest quality way.
Our key services include:
PHASE I - IIIB STUDIES:
- Data base of the potential best clinical sites in the managed countries. Project Management Clinical Site Management Clinical trial monitoring Institution and Investigator Contract Management Accomplishing the successful Regulatory and IEC Submissions
- Site Management including site recruitment and selection, remote data quality review, essential document collection, and regulatory submissions if applicable.
- Site Monitoring with pre- and selection visits through monitoring and close-out visits, phone contacts, reviewing the CRFs and/or e-CRFs, DCFs resolution etc..
- Providing the Site Training.
Gregmed offers to file and archive the study documentation that serve to demonstrate the compliance of the investigator, sponsor and monitor the standards of GCP and with applicable regulatory requirements in an organised way that will facilitate management of the clinical trial, audit and inspection.
We offer:
- Secure facilities with appropriate environmental controls and adequate protection from fire, flood and unauthorized access.
- Ensuring the quality, integrity, confidentiality and retrievability of the documents.
- Access to archives restricted to authorised personnel only.
- Preparing an archive index/log.
- Maintaining the proper duration of archiving.
- Confidence all local and international laws regarding filing and archiving of Trial Master Files are applied including Annex 1 to Directive 2001/83/EC and GCP requirements CPMP/ICH/135/95.