Study Build Functional Service Provider (FSP)

Partner with clinical data experts to accelerate Electronic Data Capture (EDC) implementation

Reduce cycle times and collect the right data with fast, efficient study builds

Robust clinical data collection is the cornerstone of any trial. Applying unparalleled knowledge of the Medidata platform, eClinical Solutions seamlessly handles the design and execution of electronic data capture (EDC) study builds across your entire clinical trial portfolio. Our credentials include extensive cross-therapeutic experience including rare disease, oncology, and immuno-oncology indications.

15

Years’ partnership with Medidata

8

Medidata accreditations

500+

Studies delivered in RAVE

Streamline electronic data capture (EDC) implementation across multiple studies

With the expertise to create customized solutions for even the most complex protocols, the eClinical Solutions team delivers significant standardization and timeline efficiencies across multiple builds, reducing cycle times and increasing research productivity, while achieving maximum quality. Efficiency gains include:

5-7 weeks average accelerated build time after multiple studies
Up to 60% timeline savings compared with industry average through standardization

Collect the right data for innovative and speed-driven trials

Partner with eClinical Solutions for your EDC implementation requirements and benefit from:

Deep Medidata expertise gives flexibility to customize and build solutions across therapy areas and trial types.
AI-powered processes boost quality and speed while promoting strategic focus.
Precise protocol to eCRF translation enables faster start up and reduces sponsor oversight time.
Agile ‘future-proof’ design simplifies protocol amendments and mitigates data collection challenges for today’s innovative and speed-driven trials.
Silo-free communication End-to-end lead programmer assignment and executive oversight streamline communication and simplify delivery.
Proactive partnership for scale Global team blending on and offshore data acquisition talent delivers high value and maximizes productivity across time zones.

“

[The eClinical Solutions’] team’s knowledge of Karyopharm data standards and processes

combined with their expertise in data collection platforms and clinical data management practices helped us meet our accelerated timelines for this important new research.

Kristan Gallitano
SVP Development Operations
Karyopharm Therapeutics

Functional Service Provider (FSP) delivery approach

The eClinical Solutions team will partner with you to:

Consult on the best database design approach and module configuration for individual trials and programs
Plan and execute study builds in Medidata RAVE across your portfolio
Assure access to qualified data acquisition personnel with the skills to support across therapeutic areas and phases of development
Develop efficiencies from build to build and ensure standardization and optimized processes
Flexibly manage capacity and meet timelines across multiple trials
Augment technology and capabilities of the in-house team

FAQs

What is unique about your relationship with Medidata?

Sponsors working with Medidata and eClinical Solutions 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. eClinical is the only Biometrics Services provider that is dedicated to the Medidata Rave platform with 8 Medidata certifications and 15 years of partnership.

Do you only do study builds using the Medidata 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 only perform Rave study builds. eClinical Solutions could support clinical data management activities using other EDC systems, but we believe in having the deep expertise and experience needed to master study database configuration.

How do you assure the quality of your EDC study builds?

Our approach is to embed quality through processes, people and technology. Achieving quality while working at speed needs a multi-faceted approach with robust processes, the right skills, and deep technology knowledge.

We have set up a quality gate process across our build milestones. The Quality Gate team reviews every milestone encompassing study start-up through study close to ensure all our endpoints are met from a compliance/eTMF standpoint.

What is the benefit of having protocol-trained clinical data acquisition team members?

The fact that our entire team is protocol trained means that they can translate the protocol directly into an eCRF rather than working from pre-written specifications. This saves time at project kick-off, and often reduces the oversight burden for sponsors extensive review of specifications is not needed. Instead, we spec as we build which streamlines the entire process.

Clients

Learn more about our clients...

From high-growth emerging biotechs to the largest life sciences companies in the world, learn how clients are partnering with eClinical Solutions to transform clinical research and drive real measurable results.