Clinical Data Services, Accelerated by Technology
Stay agile and proactively manage clinical programs with expert data services that put you back in control
eClinical Solutions Clinical Data Services
The eClinical Solutions professional services team leverages deep clinical trial expertise together with core technology platforms including Rave Clinical Cloud and the elluminate® Clinical Data Hub. The result? Clinical trial data services that enable collaboration and empower clients with data access, faster decision-making, and agile flexibility to program changes.
Data Acquisition
Unrivaled data acquisition services include high quality database design and builds using Medidata Clinical Cloud™ for your complex and innovative trials
Data Management
Our integrated, agile approach separates eCS from other clinical data management companies by combining technology, process and experience for maximum efficiency
Data Conversion and Standardization
Tech-enabled approach to shorten submission timelines and an improved ability to support real-time creation of “submission ready” datasets
Biostatistics and Statistical Programming
Experienced biostatisticians and SAS programmers provide strategic statistical input and programming to optimize clinical development and ensure regulatory compliance
Functional Service Provider
Flexible and scalable solutions support your unique functional needs, with global resources ready to deliver high-quality results as an extension of your team
elluminate Implementation
Customized implementation services are based on your organizational data strategy and needs to ensure business transformation and ROI
Data Acquisition
eCS technical teams and clinical data managers are industry experts in leveraging Medidata Rave and its suite of modules for clinical data acquisition. Each implementation team is singularly focused on quality delivery with a commitment to zero defects in the configuration and build of each clinical trial.
- Accredited Medidata partner dedicated to Rave EDC for builds
- Process standards reduce development time for subsequent studies
- Experienced teams build for downstream changes, use and analysis
Data Management
The eCS data management approach unifies the efficient utilization of technology, processes, and experienced personnel to provide rapidly accessible insights on all your collected data. Consultative and experienced data administration professionals help implement a Clinical Data Management plan that allows stakeholders to efficiently analyze and act upon clinical trial data.
- Best practices-based, technology enabled data management
- Comprehensive clinical trial data services combined with therapeutic area expertise
- Experienced team delivers quality, value and customer-focused service
Data Conversion and Standardization
Extensive experience and expertise in building standard libraries and transforming existing data into standard formats including CDISC CDASH, SDTM and ADaM standards, providing clients with high quality and efficient data standardization and conversion services for current and legacy studies.
- Experience standardizing thousands of data sets into submission ready SDTM data sets
- Teams leverage elluminate Mapper for maximum speed, efficiency and quality of ETL deliverables
- Proven methodology for rapidly creating standards libraries for maximum quality and reusability
Biostatistics and Statistical Programming
The ultimate deliverable for every clinical trial is a data set that tells the story of your therapy and its impact on patients. Keeping the end in mind is critical and is the primary focus of the biostatistics and statistical programming team that delivers high quality data sets and statistical analyses for regulatory submission.
- Expert statistical consulting on trial design, protocols and randomization
- Interim analyses, analysis and reporting including ISS and ISE preparation
- Programming for analysis, reporting, TLFs and data conversions
Functional Service Provider
As pipelines expand, the need for qualified clinical trial data services resources can increase rapidly. The data management Functional Service Provider model provides provides clients with increased flexibility without sacrificing quality and allows for rapid on-boarding of qualified team members that act as an extension of your team while mitigating risk and expense. FSP for data management offers clients flexibility and savings.
- Data Management and Study Build FSP options
- Proven FSP model experience and framework for success
- Optimized resource and delivery model designed for quality and collaboration
elluminate Implementation
The elluminate platform provides value to numerous cross-functional teams across the R&D enterprise. The implementation consulting team helps to define the key use cases that elluminate supports along with training, process re-design and change management support.
- Implementation lead by experienced clinical researchers with in-depth knowledge of elluminate
- Includes best practices, process updates and role-based training
- Comprehensive training – instructor lead, on-demand and train the trainer options
Frequently Asked Questions
What are Technology Enabled Clinical Data Services?
eClinical Solutions data services teams accelerate your timelines and help you produce the highest quality data through expert use of technologies including the eClinical Solutions core platform, the elluminate® Clinical Data Hub, and Medidata’s Rave Clinical CloudTM.
What type of Biostatistics and Statistical Programming Services do you offer?
eClinical Solutions biostatisticians and statistical programmers lead the way for all of your statistical needs, from authoring the Statistical Analysis Plan and preparing your Tables, Listings and Figures to providing ADaM deliverables and ISS/ISE submission packages. Services include developing mapping methodologies, organizing content into a structure aligned to submission requirements, and facilitating incorporation into the submission, mapping data into clinical data repositories. eCS statistical programmers bring CDISC standards expertise and in-depth knowledge and experience in producing FDA compliant datasets and TLFs towards submission. Generate SDTM-annotated CRFs compliant with CDISC guidance and FDA requirements, as well as SDTM and ADaM Reviewer’s Guides accompanying submissions.
What is the benefit of working with a data-focused Services Provider vs. a full service CRO?
Our philosophy and model is for sponsors to identify the best in breed CROs to meet the specific needs of each trial. Data management should be the consistent cornerstone of the development program to ensure efficiencies are realized (both time and money) from trial to trial. Our entire focus is on sponsor data with our mission to make clinical data acquisition and analysis easy and intelligent to help bring new treatments to patients faster. This focus and commitment to your clinical data allows us to be efficient, have proven expertise and provide a consultative approach to ensure your data meets your development requirements.
What benefits does elluminate provide for Data Services clients?
elluminate is utilized in all data services projects to provide advantages such as data integration and centralized access, standardization using elluminate Mapper, and real-time data review and visualization with Data Central and Clinical Analytics. elluminate gives both our clients and Data Managers complete transparency into the data during trial conduct and beyond, without the need for time-consuming and costly programming. You and your eCS data services team are empowered to make quicker critical decisions with powerful visualization and advanced analytical intelligence for all your clinical data from any source, in a standardized format.
What therapeutic areas do you have experience in?
eClinical Solutions is experienced in many therapeutic areas including Cardiovascular, Endocrine and Metabolic, Gastroenterology, Hematology & Oncology, Immunology, Infectious Diseases, Rare Disease, Respiratory, Urology and Vaccine. eCS project teams have extensive experience conducting complex trials such as oncology, rare disease and gene therapy.
Do you only do study builds using the Rave Clinical Cloud?
eClinical Solutions was one of Medidata’s first accredited partners to support Rave, achieving Services accreditation in 2008 and Technology accreditation in 2012. eClinical Solutions is the only Medidata partner to commit to their platform, in that we will only perform Rave study builds. eCS could support data management activities leveraging other EDC systems, but we believe in having the deep expertise and experience needed to master study database configuration.
What is unique about your relationship with Medidata?
Sponsors working with Medidata & eCS experience increased control over their clinical data through access to all trial data including legacy Rave studies across CROs and sources via elluminate. A real-time, tightly coupled integration between Rave & elluminate provides visibility, oversight, cost savings and control. eCS is the only Data Services provider that is dedicated to the Medidata Rave platform with 9+ Medidata certifications and 11+ years of partnership. You also gain maximum reuse of optimized data collection designs, standards and libraries through URL management/ownership for sponsors.