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EPharma Global

EPharma Global

EPharma Global

Pharmaceutical Compliance

Compliance Courses 

Pharmaceutical Compliance

We are a One Stop Shop addressing your compliance needs:

  • We meet your compliance needs not only through our training but tailoring our service to suit you.
  • We are the only organisation that you can contact with your compliance questions via. email at admin@epharma-global.com and our team will contact you within 24 hours to arrange a ‘consultancy service’ via through TC or via VC.
  • We are happy to work with you on a yearly subscription basis and support you on your QA requirments or you can contact as ad hoc for our consultancy services
  • We are able to share with you our over two decades of Audit experience and common findings as well discuss route causes and train your organisation in putting into place fully comprehensive CAPA’s.

If you require support for an audit we will support you in your compliance needs to ensure that you are conducting your clinical trials according to GCP and local/international guidelines.

The goal of our clinical research compliance service is to promote operational excellence, best practices, and regulatory compliance in clinical research conducted at clinical trial sites globally.

 

 

The services offered by ePharma Global include:

On-site monitoring for GCP compliance

ePharma Global are able to assist in ensuring that your site is fully compliant with GCP. During our on-site monitoring visit, ePharma Global staff review regulatory documentation and reviews subject files, including consent forms. All our on-site monitoring visits include an exit interview and a written report, both of which address all on-site observations, corrective actions, and quality improvement recommendations. Written reports are distributed to the Principal Investigator (PI) for purposes of quality improvement and education.

External audits

ePharma Global has the knowledge, expertise, and experience to assist study sites as they prepare for upcoming audits by the FDA, MHRA, NIH, sponsors, or other external agencies. Upon receipt of an audit notification, we will request an on-site review of all study files.This internal pre-audit provides the PI/study site the opportunity to identify deficiencies and take necessary corrective actions before an external audit commences.

GCP toolkit

ePharma Global will provide you with a fully GCP compliant toolkit. This serves to assist investigators with study documentation, ePharma Global provides study sites with logs, templates, and compliance checklists.

Consultation and education

Site Staff: This service provides study site staff with an opportunity to ask questions, discuss policies and address site-specific issues relating to the conduct of GCP-compliant clinical research. On-line training is available for staff to firstly help them prepare for an audit, following an audit staff can take a training course that will prepare them on how to provide concise responses to the audit report that has been issued.

Consultation for study start-up: ePhamra Global can assist investigators with "study start-up." ePharma Global can develop study-specific data collection forms to allow for the capture, access, and management of study data. In addition, ePharma Global offers assistance with study coordination, including proper record keeping and study documentation.

To submit a request for clinical research compliance services, please Contact Us

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Pharmaceutical Training’ in Clinical Research for:
Science and Nursing graduates/post graduates to train as Clinical Research Associates (CRA), Clinical Project Managers (CPM), Pharmacovigilance Associates (Drug Safety) and to gain knowledge in Good Clinical Practice and Audit Preparation and Response