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SephmerTRIALS and TrialsVisit: Understanding Benefits

What if you could speed up study-start time and find a more efficient method of identifying new investigators?

Sephmer Sciences offers two of our products: TrialsVisit and Sephmer Trials. These products were created by former monitors (CRAs) that thought about what were some of the issues that slowed to study start or the ability to meet their client needs at a CRO. This is the ANSWER!

TrailsVisit is similar to a pre-study visit conducted by a pharmaceutical and biotechnology company CRA or monitor who determines if a site will qualify to participate in a sponsored clinical trial. The Sephmer Sciences’ TrialsVisit is performed by a clinical research monitor who assesses and evaluates the suitability of a medical facility for participation in FDA-approved clinical trials prior to clinical study assignment or study consideration for new investigators and their sites.

The Sephmer Trials/TrialsVisit monitor develops a “monitoring report” that will provide physicians, their sites, and potential pharmaceutical/biotech companies with a consultative analysis documenting the medical/ healthcare facility’s ability to comply with international GCP (Good Clinical Practice) and FDA (U.S. Food and Drug Administration) requirements for a clinical trial site.

Why Use SephmerTRIALS™ andTrialsVisit™?

Accelerate Trials

SephmerTRIALS reduces the time needed to identify GCP-trained investigators (new and experienced). Using SephmerTRIALS, sponsors and CROs are able to identify trained investigators and improve study start from  weeks instead of months.

Integration with SephmerTRIALS™

SephmerTRIALS can be used in conjunction with sponsor and CRO investigator database systems because we expand your access. This integration can simplify CRO and sponsor experience while reducing time spent identifying quality investigator sites.

Improve Quality Data and Quality Sites - TrialsVisit™

Sephmer Sciences offers TrialsVisit™ which offers a pre-study visit monitoring report and facility profile that allows sponsors to take advantage of the internet as a key resource, to pre-study monitoring visits. CenterWatch reported an estimated $375 million dollars was spent on study-start up and recruitment.

TrialsVisit™ is a pre-study visit. (A visit that is made to a potential study center to determine whether the center has the experience, equipment and resources to undertake a proposed clinical trial.) Although a comprehensive pre-study visit is the process of finding Investigators who meet the needs of the protocol and evaluates the site to make sure they are appropriate for the study. TrialsVisit™ helps pharmaceutical and biotech companies save money by sending a CRA to the potential site to conduct a general pre-study visit (before protocol) which we call TrialsVisit™, to assess the site, their ability to comply with GCP, recruitment potential, evaluate if the site has access to the standard equipment used in clinical trial protocols and the workload and training of the Site Staff. Since most databases are based on physician self-reporting or disclosure there is an intrinsic bias to site selection because physician may be over-reporting their recruitment potential, quality controls for equipment, or under-estimating the workload of their staff.  

TrailsVisit™ saves valuable time and money by sponsors and CROs because our physician have a TrialsVisit™ by a trained monitor before the pre-study visit. Pre-study visits can be as much as $10,000 for one site (with travel, accomodations, transportation, staff hours, and time) for sites that may not even qualify for the protocol or be a desirable additions to your database.

Let the first visit be the Study Site Initiation visit (or Investigator's Meeting) where you train Study Site Staff Training on the specific protocol. Sephmer can help by ensuring  study site staff GCP training and discussion of regulatory procedures. Therefore your CRAs can focus on inspecting the supplies with the study site staff and getting them ready to enroll subjects. 

Reduce Trial Costs

When trials are run more efficiently, trial costs are reduced. With most trials being outsourced to CRO’s, SephmerTRIALS™ and  TrialsVisit™ can help both sponsors and CROs. Let us apply your trial parameters to our cost comparison model so we can demonstrate how SephmerTRIALS™ and  TrialsVisit™ can reduce the costs of your study.

Quick Visit and Sephmer Trials Report

The QuickVisit/Sephmer Trials  “Site Visit Monitoring Report” will also identify any deficiencies of a clinical facility which may effect participation in a “typical” pharmaceutical/biotechnology clinical trials program. The QuickVisit/ Sephmer Trials Site Report will include:

  • Facility Review
  • Hospital Affiliation
  • Patient Population Assessment
  • Disease Management Profile
  • Medical Records Access Assessment
  • Diagnostic Facility Evaluation
  • Research Conflict Report
  • Staffing Review

SephmerTrials can serve as an innovative resource database to recruit qualified and trained clinical investigators for clinical trials (phases I-III), QOL studies, and post-marketing studies for pharmaceutical and biotech companies.

We make it simple!