Just in Time GCP

In 2015, as a celebration of our 10th anniversary, DWD & Assoc., Inc became Just in Time GCP.

Founded in 2005, by Donna Dorozinsky, we have served the needs of sponsors, CROs, and clinical research sites by helping them ensure adherence to industry best practices and regulatory compliance.  What originally started as a Phase I site operations consulting firm, has expanded to include all aspects of clinical drug development from early development through regulatory approval at the sponsor, CRO, and site level, with a strong focus on regulatory inspection readiness.  Over the last decade, we have grown to provide a wide range of services that assist organizations in achieving operational excellence and regulatory compliance through all phases of development.  We are focused on helping our clients with real time implementation of good clinical practices. We are your real space time solution to your organization’s GCP needs.

Please browse our website to learn more about the wide range of services that we offer with additional information on how we can support your regulatory compliance needs.


Multiple webinars covering topics related to TMF Management

our services

  • Procedural Documents
  • GCP Training
  • Quality Control Activities
  • Quality Assurance Activities
  • CAPA Management
  • TMF Quality Control Support Services
  • Application of TMF Reference Model
  • TMF Mapping
  • TMF Management
  • TMF Procedural Documents
  • eTMF Vendor Selection
  • Mock Inspections
  • TMF Audit
  • Response to FDA 483 and Warning Letters

  • TMF Audits
  • Investigator Site Audits
  • CRO Audits
  • Vendor Audits
  • Standard Operating Procedures
  • Job Descriptions
  • Staff Orientation Programs
  • Preparation of Study Budgets
  • Clinical Trial Office Services
  • Site Operations
  • Contract Quality Assurance Services
  • CPU Operations
  • CAPA Management
  • Regulatory Inspection Readiness
  • Process mapping
  • Procedural Documents (SOP) – Full Services
  • TMF Management
  • Good Clinical Practice
  • Human Subject Protection
  • Quality Management Systems
  • Team Meeting Facilitation
  • TMF Management

We provide training for all aspects of your clinical research operations. Programs can be customized to your organizational processes. Contact us to see how Just in Time GCP can help get the most out of your people!

Quality Management Systems


Driving efficiency and quality in clinical research.

A Quality Management System is the cornerstone of a clinical drug development program. Just in Time GCP is the solution to all of your quality systems needs. We work with your organization to establish process and supporting procedural documents.  We assist you in identifying quality control and quality assurance systems to drive for the highest quality data.

TMF                   Management



We help your organization harness the power of an eTMF to drive quality and ensure inspection readiness. We offer strategies for implementing a successful eTMF system.

Regulatory Inspection Readiness


Ensuring the Organization is Inspection Ready at All Times.

Just in Time GCP has extensive experience in preparing organizations for regulatory inspection.  We assist our clients in preparing for the inspection, managing the inspection, and responding to regulatory findings.  Organizations today cannot risk non-approval because they are ill-prepared for inspection.


  • Director Research Program, Large Community Teaching Health System
    Donna Dorozinsky was instrumental in helping us build the foundation of our clinical research program. She provided focus and guidance in developing all of our standard operation procedures, but also developed processes for training and integration into our system. Having a clinical background and vast experience in clinical research she has the credibility needed to take on large site-based projects. Continue Reading...
  • Senior Medical Director, Clinical Pharmacology Unit
    DWD has great experience in the early phase CPU field, and brings that to the client in a friendly and professional manner, in a timely and cost effective manner. She says what she’ll do, and does what she says.  I’ve used her services in 3 different CPUs for different scope projects containing SOPs, staff training, and operations enhancements: and all Continue Reading...