Case Studies
Collaboration, innovation and transformation, an end-to-end approach for direct to patient studies
Background
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- Treatment experience validation study – ePRO
- 320 patients enrolled across 38 sites
- 31% enrolment and engagement rates
- Clinpal platform contributed at every touchpoint of the DCT
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Phase 3 Study involving Social Media Recruitment, eConsent and Bring Your Own Device ePRO
Background
- More than 1,000 patients pre-screened in under 4 weeks
- Electronic informed consent / assent for volunteers, parents and guardians aged 13 and over
- Daily Diary for 12 months
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Patient Questionnaires in a Depression Study
Background
- Clinpal supporting 120 patients over 18 months
- Hybrid study combining visits, telephone visit and intervention at home with self-reporting
- Digital theraputic to be delivered via smartphone
- Data collected
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Global Registries in Cardiovascular
Background
- Clinpal deployed in two registries with 10,000 and 6,000 patients
- Deployed in 41 countries
- Launched in 2015, study is ongoing
- Advanced dynamic eCRF reduced monitoring and site work
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Decentralized Diabetes Study
Background
- Decentralized, remote diabetes study assessing the insulin efficacy against food intake, sleep and exercise
- Combined electronic Blood Glucose meter (3G) backed by cloud services
- Online patient recruitment only
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Clinpal – ePRO Instruments and Questionnaires
| Capture for Patients | |
|---|---|
| SF-36 and SF-12 | WPAI:SHP |
| ACTS (Anti-Clot Treatment Satisfaction) | RAPID3 |
| DTSQ (Diabetes Treatment Satisfaction Questionnaire) | ACCEPT |
| HFS (Hypoglycemia Fear Survey) | TRAN-QOL |
| TSD-OC (obesity-related disability) | SAPASI |
| SarQoL | PSI |
| ASQ-3 6 and 12 months | Several medication adherence and assessment diaries (daily, weekly, on demand) |
| EQ-5D-5L | Satisfaction Survey with Study Participation |
| Brief Pain Inventory (BPI) | |
Selected Clinpal Deployments
| CLIENT | INDICATION | PHASE | DESCRIPTION | COUNTRIES |
|---|---|---|---|---|
| TOP 10 PHARMA | Diabetes | IV | Fully remote, online trial, using a SMART glucose meter integrated with Clinpal to capture blood glucose measurements in real time. 50 patients,1 study site. Study completed with excellent results. Click here to request more information | FI |
| TOP 10 PHARMA | Thrombosis | N/A | Bring Your Own Device (BYOD) eCOA validation study. Scientific work to develop a methodology and validate an ePRO patient questionnaire for use with patient’s own devices. Involving 25 patients in Spain and Finland. | ES, FI |
| TOP 10 PHARMA | Asthma | III | Site engagement portal with e-Learning, and site documents. Deployed to 140 sites, covering 10 e-Learning modules and an extensive document library with over 15 folders. | RU, BG, ZA, NZ, UA, BR, AU, SK, GB, PL, RO, US, CA, GE |
| TOP 10 PHARMA | Asthma | III | Moderate to severe asthma and other related indications. Clinpal is utilized across this important program as the patient recruitment and engagement solution as well as a site portal. Several studies, 2,000+ patients, 400+ sites in 8 countries. | US, CA, MX, JP, AU, ZA, GB, UA |
| TOP 10 PHARMA & RESEARCH INSTITUTE | Thrombosis | IV | 10,000 patient registry study, 500 sites, 28 countries. Clinpal is used as a comprehensive data capture solution, including eCRF’s, electronic patient questionnaires and site support features. | GB, US, CZ, IT, RU, ZA, DE, CA, TH, NL, DK, TW, AU, KR, MY, HK, CN, AR, CH, TR, AE, BE, JP, MX, ES, EG, FR, BR |
| TOP 10 PHARMA & RESEARCH INSTITUTE | Thrombosis | IV | 5,000 patient registry study, 700 sites, 18 countries. Clinpal is used as a comprehensive data capture solution, including eCRF’s, electronic patient questionnaires and site support features. | GB, PL, NL, AU, RU, DK, DE, SA, IT, AE, FR, ES, EG, CA, SE, BR, NO, MX |
| TOP 10 PHARMA & GOVERNMENTAL RESEARCH SERVICES | Diabetes | IV | 900 patient Diabetes registry. In a unique EHR/EMR integration study, Clinpal is used to recruit sites and patients based on a pre-qualification of candidates from an interface with national electronic medical records. | GB |
| Clinpal is used for candidate assessment screening, randomization, letter production and patient (ePRO) questionnaires for direct eSource data capture and integrated Protocol and GCP eLearning. Clinpal utilizes CDISC standard for data interchange. | ||||
| MEDICAL DEVICE COMPANY | Glaucoma | IV | 500 patient registry study for a medical device company. Using Clinpal for site training and data capture. | FR, BE, ES, DE, CH |
| BIOTECHNOLOGY COMPANY | Obesity | IV | Innovative observatory study involving 300 patients in 4 countries. Clinpal is used for patient recruitment and engagement as well as data capture directly from patients using biometric devices, electronic patient reported outcomes (ePRO) and eCRFs. | FR, US, IT, BE |
| BIOTECHNOLOGY | Cystic Fibrosis | Methodology | A methodology study that incorporates several novel aspects of clinical trial conduct. Clinpal is used to support electronic informed consent, consolidation of audiometric tests, eSource data capture directly from patients, patient questionnaires, ePRO validation, and a patient-centric reward program that gamifies the clinical trial experience. | US |
| MID SIZED PHARMA | Obesity | IV | Design of a patient engagement platform to support a long term nutritional observational study. | US |
| BIOTECHNOLOGY | Oncology | IV | Observational study assessing inner health in 100 adult patients recruited in Australia who have received or are currently receiving anti-cancer medications. Clinpal is used for patient recruitment and engagement as well as data capture directly from patients using biometric devices, electronic patient reported outcomes (ePRO) and eCRFs. | AU |
| DIGITAL THERAPEUTICS | CNS / Depression | II | 100% remote randomized study with 120 participants and a single virtual site consisting of the investigator and a study therapist. The objective is to evaluate the efficacy of a digital therapy app for the treatment of depression and anxiety. | FI |
| BIOTECHNOLOGY | Cystic Fibrosis | IV | Scientific review and usability evaluation of a battery of eCOA / ePRO instruments in advance of deployment into a clinical trial. | USA |
| RESEARCH INSTITUTE | Oncology | I | Digital patient outreach and recruitment solution for a challenging oncology trial. | ES, FR |
| CONSUMER PRODUCTS COMPANY | Nutrition | Validation Study | Usability testing and validation of a new eCOA instrument that measures the efficacy of a functional food product for infants. | GB |
| CLINICAL RESEARCH ORGANISATION (CRO) | Women’s Health | III | Patient engagement and site engagement portals with eLearning, eConsent, ePRO and various patient engagement functionality. Deployed at 50 sites to 900 patients. | US, CA |
| CALL CENTER PARTNER | Ophthalmology | HEOR | Health economics and outcomes research project with 100 patients, supporting patient identification and enrollment. | US, CA |
| TOP 10 PHARMA | Autoimmune disorder | Validation Study | Non-interventional, multicenter, instrument validation study with 1,500 patients. | GB |