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Feasibility Studies/Site Selection

  • After discussing your protocol, we can either use your list of poential sites, create one of our own or a combination of the two. 

  • We will create the feasibility questionnaire and after sponsor approval, distribute to sites. 

  • We will collect the responses, collate the results and make suggestions regarding site selection. 

  • Our service includes a second round of submissions (after discussion of initial results) of the fesability questionnaire to potential sites if the sponsor feels the need for additional information.

eTMF & Auditing

  • We will train on and use your current system

  • Documents (hardcopy) can be shipped to us for scanning and filed into the eTMF or electronic copies can be sent to us for filing

  • Will regularly audit the eTMF and alter you of missing documents

Clinical Supplies

  • After protocol review and discussion of supply needs, we will obtain pricing from vendors (your preferred vendors or ours) for approval

  • We will assist with creation of lab kits, printing of manuals (if in hard copy), etc. 

  • We will coordinate and assist with shipping to the sites

  • Will work with you to create resupply scheme as needed and assist with resupply 

  • If there are any supplies to be returned at site closure, we will work with the CRAs to facilitate this activity

Registering/Updating www.clinicaltrials.gov

  • Will register your study on www.clinicaltrials.gov and provide you with the NCT number

  • Will continue to update the record as needed (add sites, update information, etc.)

  • At the end of the study, will update final results with your assistance

Clinical Trial Management

Looking for a consultant trial manager to oversee the entire study? Please contact us to discuss this option as well!

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