Technology and Decentralized Trials
Integrated Industry Leading Systems to Meet Your Trial’s Needs
SDC’s transformation to meet the needs of decentralized clinical trials of the future starts with the patient and comprises a comprehensive end-to-end technology solution that integrates paperless trial capabilities with consolidated reporting across platforms.
EDC, IRT, eCOA/ePRO, eSource, eConsent, eReg, and Safety all deployed on industry leading software with SDC Insights as a software agnostic reporting backbone.
Our newest technology release is based on our specially designed warehouse (SDC Data Hub) that allows us to not only centralize data across platforms but also deploy data out from one system to another to reduce redundancy in data entry.
With single sources of truth we ensure that the information generation comes from the correct source as reports are only as good as the data behind them.
SDC Capture™
SDC Capture provides an efficient and easy to deploy ePRO/eCOA solution to meet your cost and timelines needs.
EDC / IRT
Leading technology options licensed via trusted and proven partnerships with the industry’s best providers
eSource
SDC is proud to partner with CRIO to bring eSource functionality in house.
Safety / PVG
A unique alternative to traditional SAE data collection and reporting.
Technology Solutions
Clinical Trial Budget Management
(CTBM)
Clinical Trial Management System
(CTMS)
Electronic Consent
(eConsent)
Electronic Clinical Outcomes Assessments
(eCOAs, ePROs, ClinROs)
Electronic Data Capture
Electronic Regulatory
(eRegulatory)
Electronic Source
(eSource)
Electronic Trial Master Files (eTMF)
Interactive Response Technology (IRT) for Randomization & Trial Supply Management (RTSM)
Investigator Portal
Patient Recruitment
Risk and Remote Based Monitoring
(RBM)
Safety & Pharmacovigilance
SDC Capture™
A flexible ePRO technology
SDC Capture™ is designed to fit around your protocol with workflows and decision trees to support.
SDC Capture™ is a flexible ePRO technology designed for rapid deployment in order to meet both the budgets and timeline demands of modern clinical trials.
SDC Capture™ brings three main capabilities:
Real-time electronic collection of Patient Reported Outcomes
Photo and Video Capture – 21 CFR Part 11 compliant storage
Reminder notifications to ensure protocol compliance
Real time compliance driven payment solutions
SDC Capture™ is designed to fit around your protocol with workflows and decision trees to support. Our ePRO technology has been patient tested to ensure we are able to support a diverse population and improve the patient experience. SDC Capture™ was created with a design in mind to help relieve patient burden and provide a more collaborative experience during your study.
EDC / IRT
Helping you make informed decisions.
SDC offers our clients leading technology options licensed via trusted and proven partnerships with the industry’s best providers. We evaluate each project based on study design, therapeutic area, location/language requirements, etc, and make recommendations to our clients regarding the optimal technology solution for their studies.
SDC has completed a robust qualification process for each of our preferred technology partners. This process includes thorough qualification auditing as well as SDC’s independent fit- for- use validation for each of these systems.
Mednet
Mednet is a healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Mednet’s all-in-one eClinical platform improves the efficiency of clinical studies of all types and sizes. Beyond electronic data capture (EDC), Mednet’s comprehensive solution set provides the tools required to build and manage all types of clinical research, while enabling organizations to adapt to evolving demands and requirements.
Partnership Highlights:
SDC is the premier iMednet eClinical partner
SDC preferred EDC solution since 2012
200+ successful iMednet database builds, including 10+ successful product submissions/approvals
All EDC development services performed by SDC team
Cloud-based Software-as-a-Service Technology
Browser-based access; no software needed
Supports industry standards: CDISC, HIPAA, 21 CFR 11, GCP
Fully integrated IRT/ RTSM functionality
All EDC development services performed by SDC team
Full independent “fit-for-use” validation completed and maintained by SDC
Full integration with external systems via secure API including SDC Insights
Example iMednet Dashboards
Datasets on Demand
Medidata
SDC has been supporting studies utilizing Medidata Rave for 10+ years. This experience has included 40+ studies across multiple therapeutic areas and all study phases.
Industry leading eClinical platform for 10+ years
SDC has been an accredited Medidata Build Partner since 2017
In-house custom function development and core configuration management
40+ Rave EDC builds completed, 20+ RTSM builds completed
Full integration with external systems via secure API including SDC Insights
Medidata Rave Dashboard
Medidata Rave Dashboard
Centralized eLearning Portal
Example Rave Reporting
Oracle Clinical One
Clinical One is a leading-edge platform that truly unifies people, processes, and data to simplify and accelerate the clinical trials of today and in the future. SDC has years of experience working with Clinical One to deploy large scale clinical trials.
Other Technology Options
In addition to these technologies, SDC has extensive experience and frequently supports studies in a variety of other eClinical platforms upon client request.
eSource
SDC is proud to partner with CRIO to bring eSource functionality in house to better serve our Clients and their clinical needs. With SDC’s in house builders we can better create and meet the individual needs of each protocol.
eSource provides:
Time savings
Recruitment quality vs. data transcription time
Clear focus on clinical trial data.
Site ability to customize and augment while realizing time savings and increased quality and compliance
Our eSource solution is a comprehensive, 21 CFR Part 11 compliant system enabling study staff to capture data in real time.
Eliminates majority of paper while improving data quality significantly
Ability to login anytime, from anywhere to understand the audit trail, questions, answers and any source changes without the CRA seeing internal queries
Upload, route, and mark up and sign documents such as lab reports, ECG tracings, or patient diaries. View files assigned to you for signature, and get alerts when your PI signs them
Capture real time data while reducing entry time, minimizing duplicate data entry, reducing monitoring visits and optimizing SDC’s Data Management services
Safety / Pharmacovigilance (PVG)
SDC recognizes the importance of robust yet flexible solutions when it comes to SAE data collection and reporting, and as such we now offer multiple integrated options to meet your safety/PVG needs.
eSAE workflow within EDC
SDC is proud to be the first CRO to offer our clients a unique alternative to traditional SAE data collection and reporting.
For studies not requiring global safety reporting or surveillance, SDC offers an eSAE solution:
allows for end-to-end safety data collection and reporting directly from our preferred EDC platforms.
reduces sites’ time burden while also pulling in data already entered into the AE case form.
integrated Serious Adverse Event, UADEs, and AESIs data collection, processing, reporting and SUSAR reporting window alerts within our validated EDC systems, iMedNet and Rave, reducing manual workload while increasing accuracy and efficiency of data entry, collection and reporting.
real-time notifications to specified study safety team members.
SafetyEasy®
For clients/programs requiring the gold-standard in global safety reporting and surveillance, SDC also offers Multivigilance management through the SafetyEasy® Suite. SafetyEasy® conforms to FDA, EMA, and MHRA requirements, while staying current with the everchanging regulatory landscape. SafetyEasy® provides an intuitive user interface for collecting and importing data, easily generating narratives, smart MedDRA coding, and one-click submission of regulatory reports in multiple formats (MedWatch, CIOMS, MedDev, etc.). SafetyEasy® helps manage adverse event reporting and stay compliant with current regulations and has been used for drug, device and cosmetic trials.
