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 a team of professionals 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 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

Consultation & Strategic Planning
Protocol Review
EDC Specification
CDISC Configuration & Medical Coding
eCRF Design & Build
Edit Check Programming

eConsent Setup
Randomization Setup
Direct Data Capture (DDC) Setup
Electronic Diary & Survey Build
Central/Local Laboratory Integration
Lab Range Normalization

VMP Creation & Review
Validation & UAT
Report & Export Configuration
Mid-Study Changes

Clinical Data Management

eCRF Completion Guidelines (CCG) Creation
User Administration & Training
DMP Creation & Review
Clinical Data Management (CDM)
Data Entry & Review
Data Analysis & Cleaning

Data Migration & Archival
Query Management & Reconciliation
CDISC Conversion & Medical Coding
Reporting & BYO Setup
eCasebook Approval & Locking
Proprietary eTMF Management

Clinical Programming

Patient Profiles
Edit Checks & Listings
SDTM Mapping & Conversion
SAE Reconciliation
Adjudication Reports
Cell Therapy Tracking

Programmatical Data Transfers
API Integration
Third Party Integration

Remote Monitoring

Site Monitoring
Data Monitoring
Site Management
Recruitment
IP Monitoring
Regulatory Monitoring

Interactive Response Systems (IxRS)
Site Qualification Visit (SIV)
Interim Monitoring Visit (IMV)
Close-out Visit (COV)

Clinical Compliance

Regulatory Compliance
Protocol Compliance
CDISC Compliance
CDASH Compliance
SOP Adherence
Process Optimization & Efficiency

21 CFR Part 11 Compliance
GCP Compliance
GCDMP Compliance
ESD Compliance

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