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SITE SELECTION

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  • Feasibility studies
  • Pre-study visits
  • PI contracts management
  • Investigators meetings

Feasibility studies: Before launching a trial in Argentina, and during the development phase of the protocol, we perform feasibility studies, generating recommendations in the early phase of planning. We are able to respond to very tight timelines, contacting personally recognized investigators, in order to find out the actual and future recruiting possibilities, recruitment strategies, interest and/or possibilities of performing specific sub-studies and site facilities amongst other, assuring a fast feedback from the sites.

Pre-study Visits: we perform pre-study visits sending to the Project Manager assigned to the study and/or a senior CRA. We prepare the presentation, visit all facilities and meet with the principal investigator, co-investigators and laboratory and pharmacy staff when required, evaluating the suitability of the site, the PI, the facilities and also consider eventual regulatory disadvantages of the site generating a complete report that will help to decide whether the site is ready for start up.

PI contracts Management: we act as intermediate between the sponsor and the Principal Investigator in the agreements with regards to the contracts and also help out with payment procedures throughout the study in order to facilitate the ways both for the sponsor and the investigator.

Investigators Meetings: on request, we organize Investigators meetings, taking care of all the details, whether it is a small informal meeting or a large multi-center meeting. Whether a representant of the sponsor is able to join us or not, we can handle the presentation of the study, training the assistants on protocol rationale and drug background, specific proceedings,, GCP-ICH concepts, and all applicable regulatory guidelines.

 

llbm The key to have a site seriously involved in the trial, motivating the patients, lowering the drop out rate, is to have a close communication with the site staff since the beginning of the study. At LBBM, our communication is not only through the monitoring visits, we are available to the investigators almost 24 hours in order to address urgent needs or questions. Through our network, we know who is who in the several areas of health care, and are able to select the most excellent teams for your trial. llbm