Co-operation

Based on your brief we will undertake following steps to ensure smooth and timely trial initiation and delivery.
After having received basic information (protocol synopsis if available), we perform country feasibility (epidemiology situation and availability of patients, standard of care for a specific condition, regulatory environment) and, depending on the size of required population, we also evaluate the feasibility in other European countries with our partners.

We believe the initial phase is crucial to meet the milestones on time. Through our partner network, we are able to deliver large multinational projects acting as a main and single point of contact for our sponsor. Learn more about our international cooperation.

We propose to perform pre-study visits and in trials with challenging logistics also one dummy run for one fictitious patient recruitment and sample shipment loop per country preceding the finalization of the detailed Trial Implementation Plan with enhanced Risk Analysis Plan and Risk Management/Mitigation Strategy. Such an approach prevents future delays during the implementation phase of the project, and allows us to identify all the risks beforehand.

List of the sites for pre-study visits will be prepared by local PM.

Pre-selection will be done from sites:  

  • Proposed by sponsor
  • Proposed by Key Opinion Leaders
  • Known from other trials
  • Recommended by already contacted /cooperating investigators
  • Known by Pharmnet staff
  • New sites estimated as suitable ones.

Basic information is then obtained and checked by local PMs and/or CRAs (about health care establishment, equipment available at the departments, prospective investigator(s) qualification, access to trial population etc.) on the internet or within local information resources.

Project Manager or senior CRAs contact the sites. This first contact is done by phone. The caller provides the sites with a brief characteristic of the trial. Before any confidential information is disclosed to the site, the investigator signs Confidentiality Agreement. Interest of the investigator to participate, professional background, experience and language skills, accessibility to subjects, technical and administrative background of the site, and regulatory and contractual issues are shortly discussed and assessed.

Project Manager reviews / extends the List of potential sites with information obtained during the first contact call and will propose sites qualified for pre-study visits. All sites are approved before the pre-study visit by Pharmnet.

After evaluation of all site-related information obtained from the beginning of the project, a final list of participating sites is prepared and submitted to sponsor for review. Based on this list, a further regulatory and contractual activity is initiated. 

 

Co-operation

ISO Across Alliance
We are going to California!Meet us in September at Outsourcing in Clinical Trials.http://www.arena-international.com/octsocal 
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