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

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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

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Clinical Trial Budget Management

(CTBM)

N

Clinical Trial Management System

(CTMS)

N

Electronic Consent

(eConsent)

N

Electronic Clinical Outcomes Assessments

(eCOAs, ePROs, ClinROs)

N

Electronic Data Capture

(EDC)
N

Electronic Regulatory

(eRegulatory)

N

Electronic Source

(eSource)

N

Electronic Trial Master Files (eTMF)

Interactive Response Technology (IRT) for Randomization & Trial Supply Management (RTSM)

N

Investigator Portal

N

Patient Recruitment

N

Risk and Remote Based Monitoring

(RBM)

N

Safety & Pharmacovigilance

SDC Capture’s BYOD

The most cost efficient ePRO available

In an era where flexibility and efficiency are paramount, SDC Capture’s Bring Your Own Device (BYOD) ePRO solution is a game-changer for clinical trials.  This state-of-the-art ePRO platform, now including BYOD in addition to providing provisioned devices when needed, completely eliminates paper from the clinical trial process, paving the way for greater efficiency and adherence. Several distinct advantages include:

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Elimination of Paper

By fully digitizing data collection, the BYOD ePRO solution eliminates paper forms, reducing waste and errors while streamlining data management and accelerating processing.

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Affordability

Utilizing participants’ own devices eliminates the need for additional hardware, significantly reducing costs and simplifying logistics. This BYOD approach, coupled with our rapid and cost-effective development costs makes SDC Capture the most affordable and efficient ePRO solution available.

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Enhanced Participant Adherence

Our intuitive platform seamlessly integrates into participants’ daily lives, allowing them to use their personal devices for easy engagement and compliance with study protocols, enhancing adherence and data accuracy. Patient burden is reduced which also enhances patient recruitment and better supports patient retention.

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Seamless Integration

Empower participants to use their own devices, ensuring smooth, hassle-free data collection with a user-friendly experience that integrates seamlessly into their daily routines.

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Improved Data Quality

Real-time reminders, support and feedback through personal devices leads to higher quality data and more reliable trial outcomes, benefiting both researchers and participants.

SDC Capture is also 21 CFR Part 11 compliant and fully validated in alignment with the highest of industry standards.

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:

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SDC is the premier iMednet eClinical partner

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SDC preferred EDC solution since 2012

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200+ successful iMednet database builds, including 10+ successful product submissions/approvals

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All EDC development services performed by SDC team

Cloud-based Software-as-a-Service Technology

N

Browser-based access; no software needed

N

Supports industry standards: CDISC, HIPAA, 21 CFR 11, GCP

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Fully integrated IRT/ RTSM functionality

N

All EDC development services performed by SDC team

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Full independent “fit-for-use” validation completed and maintained by SDC

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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.

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Industry leading eClinical platform for 10+ years

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SDC has been an accredited Medidata Build Partner since 2017

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In-house custom function development and core configuration management

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40+ Rave EDC builds completed, 20+ RTSM builds completed

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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:

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Time savings

N

Recruitment quality vs. data transcription time

N

Clear focus on clinical trial data.

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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.

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Eliminates majority of paper while improving data quality significantly

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Ability to login anytime, from anywhere to understand the audit trail, questions, answers and any source changes without the CRA seeing internal queries

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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

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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:

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allows for end-to-end safety data collection and reporting directly from our preferred EDC platforms.

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reduces sites’ time burden while also pulling in data already entered into the AE case form.

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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.

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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.

See How SDC Can Empower Your Clinical Decisions

Contact us or email info@sdcclinical.com