We are not a regular broker, when you select one of our
investigators to conduct a clinical trial; we support them during the study conduction (from site selection to close out) providing the following services:
- Site Standards Operating Procedures (SOP): We have a packet of SOP
that is adapted to each partner site according to their capabilities.
- Recruitment Strategies. We developed a tool in Microsoft Access to
create a comprehensive data base to assist sites in recruitment. We also provide training in recruitment strategies to assist sites during pre-screening and screening processes.
- Web page design and maintenance.
- Study Start Up. It is our commitment to have sites open and running within 4 to 8 weeks (depend of
- Regulatory Documents audit. We conduct audits in ongoing basis to our partner sites to ensure
that regulatory documents are updated and in compliance with local and FDA regulations.
- Source documents creation and audit. We assist sites in developing study source documents. We audit
them in a regular basis to prepare sites for monitoring visits. All sites’ SCs receive training in Good Documentation Practices.
- Protocol Deviation management and Corrective Action Plan (CAP). It is our goal to avoid deviation
from the protocol. If any deviation occurs during the conduct of a trial; we assist the site in creating a CAP to avoid recurrences.
- Identification of
Adverse Events (AE) and Serious Adverse Events (SAE). We provide training to site personnel and conduct regular audits to site to identify, document and report AE and SAE according to sponsor
requirements and regulations.
- Electronic CRFs and query resolution. It is our goal to ensure that subject visits are entered in
EDC system within 5 days of subject visits and queries are resolved within 5 days of query date.