Study Builders – Your EDC development and data management partners

Your EDC development and data management partners

We are a Clinical Data Functional Service Provider (FSP)

Study Builders focuses on meeting the specific needs of each trial. From build services to data management to custom programming, we offer an à la carte approach to filling in gaps within your project team. Our flexibility enables us to provide the exact expertise your study needs, when you need it.

Study Builds

Unique Builds Since 2016

200 +

Target Therapies

Unique Therapeutic Areas

20 +

Repeat Clients

New Builds for Returning Clients

50 %

Helping You Help Others

We deliver custom, affordable solutions, tailored to your study.

As experts in database design and development, and data management, the extensive experience of Study Builders’ team spans large CROs, central laboratories, academic research facilities, and cancer treatment institutes. Having worked in such varied areas, as well as developing solutions for a wide range of indications and trial types, we have a unique, well-rounded perspective and are able to think outside of the box to deliver well thought-out technical designs.

We know what works and what doesn’t work. We also like to keep things simple. We understand that the faster your study can go live, with the greatest efficiency and accuracy, the sooner we all can help others effectively manage or be free of disease.

EDC DESIGN

Strategic Planning
EDC Specifications Creation
CDISC Standardization
eCRF Design

EDC DEVELOPMENT

Edit Check Programming
Build Validation
ePro Configuration
eConsent Configuration
Randomization Configuration
Laboratory Range Normalization
API Integration
Report & Export Configuration
Mid-Study Changes

CLINICAL DATA MANAGEMENT

eCRF Completion Guidelines
User Administration & Training
Data Management & Review Plans
Data Transfer Agreements
Data Cleaning & Query Management
Data Reconciliation & Migration
Database Lock & Archiving
Medical Coding
Metrics Reporting

INFORMATICS & CLINICAL PROGRAMMING

SDTM Mapping & Conversion
Patient Profiles
Custom SQL Edit Checks
Custom Reports
Data Analytics & Visualization

What our clients say

Our sites reported great satisfaction with how the EDC was set up and said it is one of the easiest systems to use. We are so happy with the way it all went, from set up to execution to daily use.

-Client

I cannot begin to thank Study Builders enough for all the hard work that went into getting this database to live, and earlier than we were anticipating! It has been an honor to have such a dedicated team committed to this effort. Let this milestone be one that marks our progress in improving the lives of people with cancer.

-Client

I appreciate all of your hard work and dedication, and am so grateful to have the opportunity to work along side you. I think the data will prove that we can make a difference and patients will benefit!

-Client

Study Builders' commitment was unparalleled.

-Client

I really appreciate the responsiveness of the Study Builders team.

-Client

Study Builders is one of our most trusted partners and we only hear great things about them from our clients!

-EDC Vendor

Study Builders identified adaptive and creative solutions to the challenges of our study, and guided and supported us through the different processes. Their great availability and quick turn-around capabilities helped us achieve our timelines without sacrificing quality. Study Builders is dedicated to our success, and we expect to continue working with them and extend our great collaboration.

-Client

We would not have been able to meet our EDC go-live without the dedication, expertise, and efforts of Study Builders. You are so diligent and I appreciate your work ethics.