Our Story
How It Started
In 2001, founder and head engineer Charlie Johnson was approached by emergency department physician and researcher Jeffrey Kline, who needed a better way to collect and manage data for a groundbreaking pulmonary embolism study. At the time, researchers lacked web-based tools for collecting and organizing clinical research data.
To meet that need, Johnson developed the first version of Studymaker, a web-based platform for managing and organizing clinical study data. The rise of evidence-based medicine (EBM) also increased demand for secure and compliant multi-center data collection.
The Pulmonary Embolism Rule-out Criteria (PERC) Rule was the first clinical truth that Studymaker helped establish.
Over time, Studymaker evolved into a more robust and sophisticated research platform. The company started before the introduction of HIPAA regulations and later adapted its systems to meet modern federal standards for patient privacy, security, and regulatory compliance.
As the platform expanded, Studymaker continued supporting a broad range of research efforts, including studies backed by the National Institutes of Health (NIH), academic medical institutions, and industry sponsors.
By 2012, Studymaker was utilized in its first U.S. Food and Drug Administration (FDA)-submitted study: the Multicenter Procalcitonin Monitoring Sepsis Study (MOSES). It examined mortality outcomes in patients with severe sepsis and led to the approval of procalcitonin for monitoring sepsis.
In recent years, Studymaker has increasingly focused on In Vitro Diagnostic (IVD) studies across a range of biomarkers, supporting therapies and diagnostic technologies as they enter early-stage human trials. Much of the company’s recent work has centered on biomarker-driven diagnostic tools rather than traditional drug therapeutics.
Studymaker has supported studies ranging from Relative Dose Intensity (RDI) trials to CLIA-waived diagnostic research and studies involving certified laboratory instruments. By combining electronic data capture, regulatory binder support, and CTMS-style functionality, the platform helps research teams streamline study operations while maintaining compliance requirements.
Building the Platform
Looking Ahead
Today, Studymaker operates as a small, specialized contract research organization, helping manage and support clinical studies for major pharmaceutical and diagnostics companies, including Pfizer and Moderna, while also taking on select government contracts with organizations such as the Centers for Disease Control and Prevention.
These studies are typically conducted across networks of hospitals and clinics in specific geographic regions, where patients are enrolled and monitored as part of the trial process. Studymaker helps coordinate the underlying data infrastructure and study management systems that allow those sites to operate cohesively.
In many respects, Studymaker has functioned as a software vendor, providing software-as-a-service tools to contract research organizations (CROs) and pharmaceutical sponsors overseeing clinical studies. The company has also contributed to studies involving relative dose intensity (RDI), particularly in trials where treatment dosing and patient adherence are critical to outcomes.
While database management remains a core part of the business, Studymaker’s role often extends far beyond data infrastructure. The company frequently supports study operations in a more hands-on and flexible capacity, earning a reputation for going beyond standard expectations.
Drug and device companies typically act as study sponsors, partnering with sites such as academic medical centers and community clinics to conduct clinical trials. Over more than 25 years in the field, Studymaker has built an extensive national network of relationships with hospitals, research centers, and study sites. Through that work, the company estimates it has collaborated with nearly half of the medical centers in the United States.
Studymaker also serves as a trusted connector between sponsors and study sites, helping clients identify investigators and research centers that align with the goals of a particular trial.
The company’s approach is highly individualized. Rather than simply managing databases or software systems, Studymaker works closely with principal investigators and sponsors to understand the broader objective of each study and build systems around those needs.
From study startup through execution, Studymaker emphasizes consistency, responsiveness, and hands-on support. As the company continues to evolve, it is increasingly positioning itself as a boutique-focused CRO, prioritizing tailored service and long-term relationships over scale alone.
Clients have consistently valued the focused, hands-on attention Studymaker brings to each project.
Over time, the company has built close working relationships with principal investigators and research sites, helping identify opportunities to streamline data consolidation, improve study operations, and support more efficient patient enrollment.
From its earliest NIH-backed studies to modern diagnostic and device trials, Studymaker evolved with each new generation of clinical research technology. The company built systems that could operate alongside widely adopted platforms like REDCap while continuing to modernize its own workflows, interfaces, and regulatory capabilities as study demands changed over time.
Work with Studymaker to build more effective studies and support the next generation of clinical breakthroughs.