ClinOne is utilized in morethan 2,500 trialsworldwide
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- Phebe Lamb
- 6 years ago
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2 ClinOne ClinOne is dramatically changing the landscape of clinical trial management to accelerate clinical trial execution, reduce costs and provide patients with access to life-changing clinical trials to advance medicines far more rapidly than today.
3 ClinOne is utilized in morethan 2,500 trialsworldwide Utilizedin48countries Available in6languages 1,000 sofresearchinstitutions
4 ClinOneCore Solution ClinOne providesmeasurable, invaluableresults o Changingthe landscapeofclinical trials o Increase enrollmentby93% o Reducing clinicaltrial timelinesby5.5to 14 months o Increasepatient retentionby42% o Reduceprotocol deviationsby62% o Reduceadministrativeandmonitoringcost by18% o Reducethe needto contract withmultiple vendors o Increase competitive advancementofstudieswithinresearchsites
5 Site Engagement ClinOne simplifies continuous site engagement through the study community including study updates, cohort updates, clarifications, webinars, and weekly/monthly updates. The technology provides realtime push notifications, messaging and read confirmations. The system may also be utilized for forum-like discussions across your study sitesto engage.
6 Increase Screening atpoint-of-care ClinOne intersects a patients treatment path and allows research teams to identify which study is best suited for each patient. The technology provides real-time screening for the latest protocol version. It's the second most utilized feature within the ClinOne Core Solution, screening patientswithin60 seconds.
7 Study Documents andvideos ClinOne provides access to digital study binder and quick reference guides that were previously provided through printed materials. Documents are site version specific, allowing sites to only access approved documents and protocol versions. ClinOne offers the unique ability to stream confidential and training video content directly through its web and mobile application. Recorded investigator meetings, detailed procedure videos, training videos and study updates are securelystreamedthroughthe mobile application.
8 Schedule ofevents Manager A single study can require research sites to perform 400 to 800 investigational procedures per patient, or 140,000 procedures if they have enrolled 3 patients per study across their portfolio of 30 to 60 studies. To eliminate missed procedures and unnecessary protocol deviations, ClinOne has simplified how research sites manage and organize their patient procedures across multiple studies, armsandvisitsthroughour mobile workflow technology.
9 Adverse EventsManager Adverse events can occur unexpectedly requiring investigators to rapidly respond and make treatment decisions using study-defined guidelines that are buried within an extensive protocol document. ClinOne programs the dose modifications and adverse events of special interest guidelines from the protocol and places them in a simple searchable format for investigators and study personnel.
10 Automating Referrals ClinOne displays your clinical trial to other treatment centers near your open and recruiting sites, allowing visibility of your clinical trial to referring physicians. Automated communications maintains continuousengagement.
11 Empowering Patients 40% of patients report not understanding the nature of clinical trials and fewer than 2%of patients receive information about the trials they are considering. ClinTrialConnect is reshaping how patients interact with information, providing a knowledge base portal to learn about a specific clinical trial, and allowing the patient tosharedetailswith familymembers.
12 Digital Concierge 42% of patients fail to meet study visit requirements after enrollment. Over 80% of studies fail to retain patients for the complete duration of a trial. ClinOne provides patients with a digital concierge technology to manage their clinical trial experience, assuring greater visit compliance and retention in studies. ClinOne s technology provides patients and their families a central resource to manage their visits calendar, guidance on travel/logistics with Google Maps integration, visit expectations, alerts andreminders across 30 languages.
13 Secure Messaging 92% of research sites are challenged with effectively communicating with their research patients resulting in missed appointments, insufficient preparedness for visits and lack of study engagement. ClinOne has integrated a secure messaging platform between research sites and research patients to provide HIPAA compliant, fully encrypted, continuous communication and document sharing. Study sponsors may also provide IRB approved study-level messaging, study updates, and safety updates with read confirmationswithpatientsto maintainstudyengagement.
14 Patient DocumentManagement Study document and safety update management is a critical for a patients and their families. ClinOne's Digital Concierge provides patients with a HIPAA compliant study management portal to manage informed consents, study documents and safety letters. Research sites and sponsors can upload documents into a patient s document portal to build a complete online document library to improve the patient s experience. Read confirmations are sent back to the research sites to improve compliance and documentation..
15 ClinOne cloudencryption ClinOne data resides in Microsoft Azure, the second largest cloud computing service in the world. All sponsordata andstudy content is fullyencryptedwhile storedwithinmicrosoft Azure environment.
16 ClinOne DataTransmission User and study data is encrypted while transmitted through the internet from Azure to smartphones. In addition, ClinOne utilizes SSL (Secure Sockets Layer) which is the standard security technology for establishing an encrypted link between web servers and devices/browsers. This link ensures that all data passed between the web server and browsers remain private and integral.
17 ClinOne Compliance ClinOne maintains a complete audit trail for additions, modifications and archiving of any content and user actions within ClinOne. FDA CRF Part 11 compliant. HIPAA compliance.
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