STUDY MANAGEMENT AND PLANNING
The Veterinary Consultancy will work closely with you to manage all aspects of your projects. Depending on your needs, we can collaborate with you on a project or manage it independently, always keeping you thoroughly informed. We understand the importance of a strong focus on:
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Strategic planning
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Resource management
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Preparation, execution and coordination across study sites
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Issue tracking
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Communication with the Sponsor, the study team, the study sites
Our diligence will ensure that your projects are delivered on time and on budget. Our main objective is to foster a long-lasting partnership built on trust and mutual goals.
PROTOCOL PREPARATION
Our depth of experience enables us to proficiently provide protocol writing and development of data capture form services, for proof of concept, dose determination, dose confirmation, target animal safety, clinical efficacy, and post-approval marketing studies.
Our involvement can start as early as study design discussions and continue throughout the development of the protocol including participation at formal CVM protocol pre-submission meetings.
STUDY INITIATION, MONITORING & CLOSE-OUT
Study Materials
Our development of study specific materials encompasses paper as well as electronic formats.
We will prepare and ship the notebooks for the Investigators/Study Directors, individual cases, owner diaries, and all training materials.
We will work with your specialists to help design a practical and intelligent Electronic Data Capture system.
We understand the details, and will tailor these elements to be user-friendly, and to meet all study and regulatory requirements.
STUDY INITIATION, MONITORING & CLOSE-OUT
Site Selection & Training
We choose your study sites based on our many years of performing studies throughout the US and Canada.
We begin by selecting experienced Investigators from our extensive list of proven high performers. Additional sites are then chosen through an intensive qualification process.
During a project, extra attention is given to those sites that are new to clinical studies.
The Veterinary Consultancy will provide site personnel with the tools, support, and training to ensure that your studies will run successfully.
STUDY INITIATION, MONITORING & CLOSE-OUT
Study Monitoring
Our study monitors, located in different geographical areas in the US, are highly experienced.
The professionalism and commitment of our staff ensures that the same team will see your project through to a successful completion. We have extensive experience conducting studies under GCP and GLP for pharmaceutical (including vaccine) companies, and other CROs.
Maintaining a consistent monitoring methodology among multiple sites and keeping you informed of our progress are also important elements of our approach. The well-planned frequency and quality of our monitoring visits result in final cases that will require minimal attention through the data management process, and will expedite the write-up of the final study report.
Our goal is to function as a true extension of your internal team.
DRUG INVENTORY & SHIPMENT
TVC will manage clinical trial material (Investigational Veterinary Product - IVP and Control Product - CP):
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Receive clinical trial materials from the Sponsor
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Handle and submit necessary regulatory documentation (Notice of Claimed Investigational Exemption - NCIE)
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Ship these materials to study sites
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Handle all documentation associated with their shipment and receipt
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Ensure appropriate return of all unused clinical material to the Sponsor
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Ensure all unused clinical material is appropriately disposed of
DATA MANAGEMENT
We recognize that the integrity of your data is the highest priority.
We are efficient in managing, tracking, entering, and verifying data.
We can generate well organized Excel files suitable for SAS input complete with ReadMe information, or develop an intuitive Data Entry system meeting your specific needs.
We can provide data capture form planning and design, paper or electronic format, and data entry.
QUALITY ASSURANCE
Quality Assurance during the live phase, data pack, and final report is vital to producing a dossier that will be successful at CVM.
Services include:
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Review of protocol and forms
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On-site in-life study audits, GCP and GLP
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Audits of raw data and final reports
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Facility inspections
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VICH GL9 GCPs Training
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GLPs Training
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Training in Handling FDA inspections
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Review of statistical data/reports
FDA AUDIT SUPPORT
When the FDA visits a study site, it is important to handle the audit efficiently and professionally.
We have the experience and knowledge to facilitate the audit process.
We can assist in preparing the investigative sites ensuring that study files are in good order and readily available, so requested documents can be quickly accessed, and delivered to the FDA inspector, as needed.
We can be present during the FDA audit to support site personnel.
Detailed minutes of the audit are always prepared for the Sponsor, with a copy of all documents requested by the FDA inspector.
REGULATORY AFFAIRS
We can help with your Regulatory Affairs needs when dealing with the Center for Veterinary Medicine at the Food and Drug Administration (FDA/CVM), Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). We are prepared to provide assistance with:
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Taking the lead on all contacts with CVM on all matters relating to new animal drugs
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Crafting and applying for CVM User Fee Waivers
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Acting as the US Agent with CVM for international companies with no US presence
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Preparing materials for discussion with potential development partners
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Providing guidance on the Program of Development that will be required at CVM to gain approval of the new animal drug
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Creation of the Investigational INAD for US development programs
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Protocol design to ensure compliance with CVM requirements
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Assessment of new technologies to determine the US agency of jurisdiction
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Technical Sections preparation to meet INAD submission requirements
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Seeking guidance from CVM without revealing the sponsor identify or the product
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Providing guidance and knowledge about CVM Divisions and personnel
TECHNICAL WRITING
We are committed to effective technical writing.
This includes summarizing the results of multiple studies and writing first class reports that are suitable for agency review and approval.
We will also assist in compiling and presenting adverse events (AEs/SAEs), and in answering questions from regulatory agencies.
In addition, we will compose Freedom of Information (FOI) summaries.
We will also prepare manuscripts for submission to scientific journals.