Case Studies

“ICTS study communication is by far the most comprehensive and responsive. The respond to challenges immediately and turn trend signals into results, challenges into solutions.”
Vice President, Clinical Operations, Small Biotech Firm

Special Populations

Case Study: Special Populations(Hypertension)This was an NIH Phase IV program designed to enroll two, 10,000 subject groups within a five year period for a long term (10 year) study. ICTS designed and implemented a patient recruitment program covering 528 sites in the US, Canada, US Virgin Islands and Puerto Rico in six weeks, and were contracted to send 8,000 pre-qualified referrals from the call center to the investigator sites to jump-start the recruitment for this study. In the first six wee...

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  • Published November 05 2014

Assistant Study Coordinator: Ophthalmology

Case Study: Assistant Study CoordinatorTherapeutic Area:  OphthalmologyIndication:  Dry AMDNeeded 180 patients to complete device study that had begun more than 30 months priorAfter 30 months, sites were experiencing study fatigue and were underperformingICTS identified 6 primary sites to assist with ASCs doing on site reviews and in-community recruitment for an extremely restrictive studyBefore we began work it took more than 25 referrals or internal reviews to attain one randomized p...

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  • Published November 05 2014

Integrated, Centralized Recruitment

Case Study: Integrated, Centralized RecruitmentDepression/Anxiety combined study with 6 treatment arms148 sites in US and Canada1,600 patient randomization goalVaried SC experience levelsPlan began at investigator meetingICTS SolutionsRecruitment roll-out at investigator meetingStudy coordinator patient recruitment training at investigator meetingEnrollment toolkits provided to study coordinators12 week, integrated advertising and patient communication programLocal site advertising (from stipend...

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  • Published November 05 2014

Assistant Study Coordinator

Case Study: Assistant Study CoordinatorCardiology study with very specific inclusion/exclusion criteriaLarge cardiology practices with large patient databasesToo time consuming for regular study coordinatorVaried EMR and paper recordsNo EMR off-site review process available (no EMR consistency)ICTS SolutionsAssistant study coordinator placed in siteSite pulled charts based on ICD-9 codes, age, treatment datesASC manually reviewed electronic and paper records, labs, nuclear medicine reportsPatien...

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  • Published November 05 2014

Informed Consent

Case Study: Informed ConsentRheumatology, 1 ongoing study, 1 new parallel studyCurrent consent rate at 7% and cost of randomized patient at $1,950Very difficult I/E criteriaEducated patient populationPoly Pharmacy situation with many qualified candidates, requiring wash-out and discontinuationMany coordinators mailing ICF to patients, not seen in person, as SOPTreatment working – consent rate lowICTS SolutionsEducational DVD, Modular Format, ICF CompanionStandardize delivery to include inf...

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  • Published November 05 2014

Acute In-Hospital Study

Case Study: Acute In-Hospital StudyRescue, First Patient in 18 months prior, Pivotal studyFewer than 10% of patients randomized of 186 requiredPublication Date Scheduled 9 months outReferral Chain unaware of studyIn-trial processes not being followed properlyMostly University Hospitals with local IRBsCost per randomized patient was > $15,000ICTS SolutionsIdentification of all involved and responsibilities from diagnosis to patient exitEducation of triage to treatment chainModular format DVD E...

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  • Published November 05 2014