Clinical Services

Medpole will manage your registry/study at any stage (pre-clinical, clinical or post-market surveillance), including:

· Study preparation and site set-up:

· Clinical investigational plan (protocol) and related documents development

· Site selection (including site assessment visits)

· Ethics Committee and Competent Authorities submissions

· Appointment of reading centres, Clinical Event Committee and Data and Safety Monitoring Board

· Recruitment and follow-up:

· Site opening and training

· Warehousing and distribution of product to sites

· Site monitoring

· Safety monitoring (deviation and adverse events management)

· Study closing:

· Site close-out

· Study quality check (site audits, inventory reconciliation)

· Reporting (statistical analysis, report and publication writing)

· Data management (data entry/cleaning/closing):

· Database development

· Data entry and cleaning using customized data management solutions (Electronic Data Capture systems compliant with 21CFR part 11 standards or paper Case Report Forms with double data entry)

You want to place your product on the European market on a timely manner.  You want to add value to your product at launch time.  Medpole will assist you to develop the right strategy:

· Identify the safety and performance of your product

· Identify the data required to speed up reimbursement

· Design the registry/study that meets your launch objectives

· Leverage clinical data to obtain global approval

Medpole has highly experienced staff, focusing on quality and efficiency, working fast and accurately according to the highest standards to ensure proper handling of your clinical data.

Strategy

Support