Welcome

DWD & Assoc. is now Just in Time GCP

In celebration of our 10th anniversary, DWD & Assoc., Inc is excited to announce that we are now Just in Time GCP.

Founded in 2005, by Donna Dorozinsky, DWD & Associates has 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.  Over the last decade, DWD has grown to provide a wide range of services that assist organizations in achieving operational excellence and regulatory compliance through all phases of development.  Our new company name represents our focus on helping our clients with real time implementation of good clinical practices.  DWD is now Just in Time GCP.  We are your realtime solution to your organization’s GCP need.

Just in Time GCP will continue under the leadership of Donna Dorozinsky supported by the staff that you have come to know over the years; but we are a growing organization and our new name reflects this.  Please browse our new website to learn more about the wide range of services that we offer with additional information on how we can support your organizational compliance needs.

 

NEWS & EVENTS

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Mapping the Future for Trial Master File: Advancing Standards by Harmonizing Clinical and Technical Strengths

Donna W Dorozinzky

Wednesday, June 17, 2015
8:00 – 9:00 AM, Room 202B

Standardization has become the norm across the clinical research spectrum. The industry has embraced data standards, such as MEDRA, CDISC, and eCTD. The Trial Master File (TMF) is a collection of content that demonstrates that the sponsor conducted the study in accordance with the protocol and Good Clinical Practice. In the past several years there has been an industry move to creating best practice and standardizing the Trial Master File content. Standardized TMF content ensures completeness of regulatory submission, regulatory inspection readiness and trial execution. The TMF standards are evolving to address the interoperability needs of collaboration, mergers, acquisitions, licensing efforts and records retention. This session will discuss the importance of standards in TMF and explore the currently available standards within the industry.

our services

  • Procedural Documents
  • GCP Training
  • Quality Control Activities
  • Quality Assurance Activities
  • CAPA Management
  • Application of TMF Reference Model
  • TMF Mapping
  • TMF Management
  • TMF Quality Control Support Services
  • TMF Procedural Documents
  • eTMF Vendor Selection

  • 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
  • Mock Inspections
  • TMF Audit
  • Response to FDA 483 and Warning Letters
  • 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!

01

Quality Management Systems

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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.

02

TMF Management

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Best Practice for Achieving TMF Quality

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.

03

Regulatory Inspection Readiness

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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.

WHAT PEOPLE SAY ABOUT US

  • 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...