Temecula, CA

Capabilities

Study Builders

We deliver custom solutions, tailored to you.

Study Builders, LLC, founded in 2016 and located in Southern California, is a boutique Clinical Research Organization (CRO). We are made up of professional consultants with years of experience in building and managing clinical trials. Our team has worked within large CROs, central laboratories, academic research facilities, and cancer treatment institutes. Having worked in such a variety of areas within the industry, as well having developed solutions for many different indications, we have gained a unique and well-rounded perspective to be able to think outside of the box and deliver well-thought out technical designs.

Why hire us?

We’re fast, creative, and never sacrifice quality. We know what works and what doesn’t work, and we like to keep things simple. We are purposely small with low overhead so that we can remain agile and able to quickly and effectively build affordable solutions that work for you. Utilizing your company’s existing contracts with approved EDC vendors, we design, develop, publish, and support your study databases so you don’t have to.

A Complete Solution

EDC Development & Validation

Consultation & Strategic Planning
Solution Recommendations
Protocol Review
EDC Specifications Creation
CDISC & Medical Coding

eCRF Design & Build
Edit Check Programming
Build Validation
Electronic Diaries & Surveys (ePro)
Randomization

Central/Local Laboratory Integration
Lab Range Normalization
Report & Export Configuration
Mid-Study Changes

Clinical Data Management

eCRF Completion Guidelines
User Setup & Training
Clinical Data Management (CDM)
Data Management & Review Plans
Data Cleaning & Query Reconciliation

Data Migration
Site Management
Remote Monitoring

Biostatistics & Clinical Programming

Data Analysis & Transfers
Biostatistics
SDTM Mapping & Conversion
SAE Reconciliation
Adjudication Reports

Edit Checks/Listings Programming
Data Pooling & Mining
Patient Profiles
Cell Therapy Tracking

Quality Assurance & Regulatory Compliance

Quality Assurance
Systems & Build Validation
Regulatory Compliance
Protocol Compliance
CDISC Compliance

CDASH Compliance
21 CFR Part 11 Compliance
GCDMP Compliance
Process Optimization & Efficiency

Builds by the Numbers

Builds by Study Type

  • Device
  • Treatment
  • Biologic/Drug
  • Diagnostic

Builds by Indication

  • Cancer
  • Sleep
  • Cardio
  • Allergy
  • Nicotine
  • Immune
  • Other

Builds by Client

  • Repeat
  • One-Time