Critical success factors

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The evaluation of our work to date has indicated five critical success factors:

1. Regulatory/ CEC Awareness

One of the crucial factors is to have the core documents available for timely Regulatory/Ethics submissions and approvals. We have the local knowledge and good cooperation with Regulatory Authorities and can therefore start the collection of study submission documents from the sites very quickly. Consequently, we submit the documents for conditional and partial approval by CEC and Regulatory as soon as possible. We make sure to obtain critical documents from the Sponsor as soon as they have been finalized.

2. Site Selection / Contingency Maintenance

In order to recruit rapidly, selecting the right sites is critical. Therefore we use clinical hospitals and smaller, county hospitals and sites where good recruitment is expected. To improve referral, we include as many sites as economical in order to create a good climate for patient enrollment.We keep the evidence of subject population from the site. We have regular site resource discussions about possible organizational challenges.

3. Recruitment & Motivation

In order to meet the enrollment goals within planned timelines, we have developed recruitment strategies as indicated previously. In addition, we identify potential back-up sites/countries and make Reg/ CEC submissions in parallel. Thus, we identify high-performing sites to support their further recruitment and we support sites in the organization of patient referral networks.

We focus on safety and benefit of the subjects as we do not want to lose any patients due to logistic difficulties they may encounter. We insist on reimbursement of travel expenses, organization of travel when needed, and organization of additional examinations possibly not available at the site.

4. Site Staff Training

We use different scales, EDC and, in the case of less experienced sites – ICH and GCP trainings. We organize the training of investigators at investigator meetings, SIV, first screening visit and first randomization visit for each site.

5. CRAs Permanent Training and Supervision

We have long-term contracts with CRAs located in Croatia and in Serbia. All of our CRAs have a university degree and are fluent in English, they have excellent communication and problem resolving skills, and have their workload carefully planned. We always have 2 CRAs trained for one clinical trial. All of our CRAs have at least 2 years of monitoring experience when put on the study. The are fully employed, have a business car, laptop and mobile phone at their disposal. Sermon CRAs are in permanent training .