CLINICAL SERVICES
Clinical Site Selection and Monitoring
Pre-Study / Qualification Visit: PQC Consulting, Inc. will do a complete assessment of each clinical research site,
capabilities of staff and evaluate the site's ability to adhere to FDA
regulations, Good Clinical Practices and the
overall conduct of clinical trials.
Clinical Monitoring Initiation Visit: PQC Consulting, Inc. will provide full initiation of the clinical research site which
includes but is not limited to, review of study protocol, regulatory documents, case report forms, enrollment requirements
and investigational drug accountability and responsibilities for the conduct of the clinical trial.
Clinical Monitoring Visit: To ensure quality, PQC Consulting, Inc. will provide ongoing clinical monitoring throughout the
conduct of the clinical trial. Activities include: informed consent review, eligibility verification, case report form and source
documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol
adherence and drug accountability.
Close-Out Visit: Upon completion of the clinical trial, PQC Consulting, Inc. will provide final retrieval of all data, resolution
of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug
accountability and return.
Training
Clinical Research Training: PQC Consulting, Inc. offers a customized training program, developed to improve the quality
and timelines of clinical research, which provides a solid foundation for the ethical principles guiding clinical research. The
program educates and updates research staff on ICH/GCPs, the research process and introduces participants to the standard
processes and procedures often required to work successfully with pharmaceutical and CRO sponsors. The training can
be delivered both online or in person and is suitable for all parties involved in clinical research.
PQC Consulting, Inc. can also come to your facility to conduct any requested clinical research training courses. In addition, we
can tailor our existing programs to better suit your needs and areas of focus within your organization. |
Study Coordinator Training: The Study Coordinator is an essential position in clinical research necessary for complying
with GCPs. They play the daily role that ties into every aspect of clinical research, dealing with the sponsor or contract
research organization, the IRB, the physician, the patients and even the FDA. The Study Coordinator has many key
responsibilities during the conduct of the clinical trial. PQC consulting offers training to improve your understanding
of this key role.
A well trained, knowledgeable study coordinator is essential to the success of research. PQC Consulting, Inc.
will provide comprehensive training in the field of clinical research to technicians, assistants, and nurses that do not have
research education as part of their certification requirements.
Customized Training: PQC Consulting, Inc. can train the entire staff at once in your own office setting or at one of PQC
Consulting, Inc.’s Training Center facilities with hands-on expertise. Our professional trainers will come to your office,
educate and prepare the staff to organize your research regulatory documents, learn the value of subject recruitment
and retention, and display the ability to perform as a knowledgeable research team.
Seminars: PQC Consulting, Inc. conducts full day seminars at our training facility in Thousand Oaks, CA designed for
coordinators with little or no research experience or a more advanced course designed for Coordinators with more than
12 months research experience.
Regulation Binder Training Manuals: Training manuals are provided by PQC Consulting, Inc with all training services.
These manuals provide information on how to set up and maintain regulatory binders as well as a glossary and FDA
guidance material. They are organizational tools that can be utilized to aid in the day to day functions performed by
study coordinators.
Case Report Form Design
PQC Consulting, Inc. will design and review case report forms (CRFs) to ensure that CRFs capture appropriate data for
analysis as dictated by the protocol. The goal is to create a CRF that is clear, concise, and user friendly for the investigator.
Additionally, PQC Consulting, Inc. will provide information on various approaches for data collection in the conduct of
your study.
Data Management Planning and Analysis
The Data Management Plan (DMP) outlines elements of the data management process. We make every attempt to do the
thinking up front so that the DMP is comprehensive, focused on study endpoints, and is clear and concise. The following
is standard content for a DMP:
- Study Description, Responsibilities and Contact Information
- Study Setup and Design including database design/structures, screen creation, and schema
- Study test plan and change control method
- CRF flow and tracking
- Technology specified for data capture and study specific data capture guidelines
- Safety and Efficacy Data guidelines and critical variable audits
- Laboratory Data guidelines, reference ranges, format and frequency
- Query Management
- Study Deliverables
- Transfers
- List of standard Reports and frequency
- Study Close procedures including database freeze/lock process
- Security Guidelines
- Quality Assurance
- Revision History
Once the data has been collected, PQC Consulting, Inc. can provide statistical analysis of the study results.
Clinical Project Planning
PQC Consulting, Inc. will coordinate all aspects of your study. PQC Consulting, Inc. will work closely with you to align project
objectives, define responsibilities and develop comprehensive project operating and communication plans at an early stage.
The project manager directs all activities to ensure optimal project implementation, meet timelines and milestones, maintain
excellent quality, and provide requisite training.
Project Management Services
PQC Consulting, Inc. will work closely with you to maintain timely and thorough communications, anticipate project risks, develop
contingency plans, and keep your project within budget and on target for successful completion. Throughout the course of the
study, the Project Manager regularly communicates current information and accurate status of your study. The following are
examples of Project Management services provided:
- Define the vision and scope of the project, and align objectives with project teams and our research partners
- Collaborate with our client’s internal Project Management to coordinate strategic project plans
- Define roles and responsibilities and establish performance metrics with the research partners
- Establish study assumptions with our clients to define tasks and deliverables, develop the study timeline, and identify
resources
- Identify Risk Management and mitigation strategies
- Effectively manage resources, timelines, and budgets to attain study goals. Respond rapidly to dynamic situations and
opportunities
- Encourage and support team synergy, quality, and mutually rewarding research partnerships
Audits
Good Clinical Practices Audits: Early identification and effective resolution of the issues which are identified prior to FDA
audits can save drug development time and money. PQC Consulting, Inc. can perform independent GCP audits of Sponsors,
CROs, study sites, and IRBs. Feedback from the audit can provide you with assurance that sites are in compliance with the
regulations.
Investigator / Study Site Audits:
- Verify that the protocol is performed according to GCP and ICH standards and to the sponsor's or CRO's SOPs
- Review the process for obtaining informed consent
- Ensure that informed consent is obtained from each study subject
- Review records and procedures concerning interactions with the IRB
- Review records and procedures concerning drug accountability
- Inspect study-required facilities and/or equipment
- Verify that the data collected in a representative sample of Case Report Forms (CRFs) are supported by source
documents
- Assess compliance with internal SOPs
Sponsor / Contract Research Organization Audits:
- Verify that the protocol is performed according to GCP and ICH standards
- Review records and procedures for site visits
- Review study file documentation
- Ensure internal systems used in the conduct of clinical trials are correct, including SOPs for Adverse Experience (AE)
reporting, supplies distribution, and data handling
- Assess compliance with internal SOPs
Data and Report Audits: Compare study report versus the protocol, CRFs, and database and ensure internal consistency
in reports.
Regulatory Submissions
Compare NDA, clinical overview, or integrated summaries to individual study reports and records.
SOPs and Document Management
The first step in ensuring that studies are conducted appropriately is to have well-written procedures that specifically outline
how each task should be performed. PQC Consulting can identify and develop the standard operating procedures (SOPs)
necessary for your company to implement and run a successful trial in accordance with applicable regulatory requirements.
PQC Consulting has the capability of writing customized SOPs for Study sites and Sponsors/CROs.
PQC Consulting, Inc. can also assist you in the review of your existing SOPs to determine if these comply with FDA regulations
and FDA guidelines.
Additionally, PQC Consulting, Inc. will work with your organization to tailor a document tracking system so that you are able
to successfully track all SOPs, revisions and all other critical study documentation.
