Sponsors & CROs

Overview

Operational excellence, specialty expertise and reliable data delivery.

 

Evidentis is a specialty clinical research center focused on liver, metabolic and cardiometabolic health, supported by early-phase capability and precise operational workflows. We partner with sponsors and CROs seeking high-quality data, efficient execution and engaged investigators with deep subspecialty expertise.

 

Our infrastructure supports Phase 1 through Phase 4 clinical trials, with strong emphasis on scientific rigor, participant safety, controlled workflows and responsive communication throughout the study lifecycle.

Why Sponsors Partner With Evidentis

Specialist-Led Research

All studies are overseen by a triple board-certified principal investigator with extensive experience across NIH-funded, investigator-led, and industry-sponsored trials, ensuring consistent engagement and rigorous scientific oversight.

Operational Excellence & Data Integrity

Our research team executes precise workflows, accurate data capture, and strict protocol adherence. PK timing, sample collection, and critical procedures are supported by controlled processes and real-time oversight to ensure reliable data delivery.

Proven Clinical Trial Experience

Evidentis leadership brings extensive experience across multicenter, investigator-initiated, and industry-sponsored Phase 2–4 trials in liver and metabolic disease.
Past & Current Clinical Trials

In-House Data & Biostatistics

Evidentis maintains in-house data management and biostatistical oversight, led by an experienced data scientist who works closely with CRCs to support data accuracy, query resolution, PK workflows, and overall statistical quality.

Efficient Study Startup

Evidentis prioritizes rapid turnaround for feasibility review, regulatory submissions, contract and budget negotiation and IRB activation. Close coordination with sponsors and CROs supports predictable, streamlined startup timelines.

Participant Access & Community Network

Evidentis benefits from strong referral pathways across the Dallas–Fort Worth region, including:

  • primary care and endocrinology groups
  • GI and hepatology specialists
  • diverse healthcare systems, including major safety-net providers
  • a growing clinical trial registry focused on liver and metabolic conditions
  • targeted digital outreach campaigns
  • collaboration with regional liver and metabolic programs
  • community education and awareness initiatives

This network supports reliable recruitment across liver, metabolic and cardiometabolic conditions.

Early Phase & PK Capability

Evidentis operates a dedicated overnight research suite supporting early-phase studies and pharmacokinetic (PK) protocols, with:

  • controlled research environment for protocol-directed assessments
  • timed sampling workflows for intensive PK schedules
  • overnight observation capability for extended PK windows
  • participant monitoring area for timed procedures
  • dedicated phlebotomy and sample-processing space

This setup enables precise execution of 24-48 hour PK sampling and early-phase procedures in a controlled, participant-centered environment.

Transparent Communication

Sponsors and CROs receive timely updates, clear documentation and accessible PI and coordinator communication throughout the lifecycle of each trial.

Capabilities & Infrastructure

Evidentis maintains research environments and laboratory infrastructure designed to support high-quality data collection across early- and later-phase clinical trials.

Clinical & Facility Infrastructure

  • Dedicated overnight research suite for early-phase and PK protocols
  • Controlled environment for timed and protocol-directed assessments
  • Monitored participant observation area

Laboratory Processing & Equipment

  • High-throughput sample processing and temperature-controlled storage (ambient, –20°C, –80°C)
  • Investigational product (IP) storage with controlled access
  • Dedicated phlebotomy and sample-draw area
  • Chain-of-custody–controlled specimen workflows

Power, Safety & Continuity

  • Backup generator with automatic transfer for critical circuits and cold-storage circuits
  • Secure dedicated cold-storage electrical line
  • Continuous temperature monitoring with automated alerts
  • SOP-driven handling and storage workflows

Data & Quality Systems

  • CRIO CTMS for regulatory, source, and remote monitoring
  • GCP-compliant digital workflows
  • Real-time query resolution and continuous data oversight
  • Proficiency across major EDC platforms
  • In-house data and biostatistical oversight integrated with CRC workflows

Startup & Feasibility

We provide efficient turnaround for:

Feasibility assessments

Pre-study qualification visits

Contract & budget negotiation

Regulatory & IRB submissions

SOP review and alignment

Study activation

Open communication throughout startup supports predictable, reliable timelines.

Quality & Compliance

Our processes support:

Protocol adherence

Low deviation rates

Accurate, timely data entry

Clear, auditable workflows

Consistent PI oversight & documentation

High-quality informed consent

Temperature- and chain-of-custody–controlled sample handling

Audit & pre-study visit readiness

All staff complete ongoing GCP, protocol-specific and role-specific training.

Request Feasibility

For feasibility requests, startup discussions or protocol review:

Submit your protocol synopsis, schedule of assessments or feasibility questionnaire, and our team will respond promptly.

Consulting & Advisory Services

Evidentis offers expert consulting for sponsors, CROs, clinical investigators and healthcare organizations seeking guidance in liver and metabolic clinical research. Areas include protocol input, early-phase design considerations, site-readiness planning, operational optimization and invited scientific talks.

 

Consulting services may be provided directly by the principal investigator and may include members of the Evidentis clinical and research team as appropriate to the engagement.

 

Enquiries: research@evidentisresearch.com

Strategic Partnerships

Evidentis is open to selective long-term partnerships that align with our research focus, operational standards and commitment to scientific rigor. These may include multicenter collaborations, co-developed research programs, shared infrastructure initiatives or disease-specific research networks.

 

Partnership discussions can be initiated by contacting: research@evidentisresearch.com