ACI has successfully designed and implemented more than 20 clinical trials involving more than 700 dogs and cats with cancer. These successful trials have led to a recent expansion to include trials for other veterinary medical problems for animals. Through the ACI network model, sponsors have immediate access through a single contract to experienced, well-trained investigators nationwide. All ACI network members have been carefully selected and are considered leaders in their fields. ACI oversees all trials, ensuring accurate and complete data and timely follow-up.

As a contract research organization, we partner with our trial sponsors and provide services such as:

Companion Animal Clinical Trial Design

• Portfolio management and selection of active(s)
• Comprehensive pre-IND support
• Protocol development
• Design to meet regulatory and promotional needs
• Eligibility and inclusion criteria

Regulatory Strategy

• Regulatory strategy for pre-clinical through Phase IV
• Interpretation of FDA/ICH guidelines and regulations
• Planning and facilitation of advisory committee meetings
• Preparation of FDA meeting materials
• Liaison at FDA meetings
• Preparation and submission of regulatory documents and reports

Clinical Trial Management

• Investigation site selection
• Study coordination
• Budget and timeline management
• Communication management
• Clinical review
• Safety and regulatory management

ACI Network Access and Administration

• Three ACI networks are organized around expertise and disease specialty: the Veterinary Oncology Network, the Veterinary Specialty Trials Network and the Veterinary Primary Care Trials Network.
• ACI networks include highly trained specialists and their staff throughout the U.S. and Canada. This unique structure allows for rapid recruitment and access to highly trained veterinary specialists at premiere veterinary clinics across North America.
• Sponsor relationships are with ACI; the individual network members/investigators are bound to a contractual agreement with ACI
• Payments to the clinics for patient care and oversight are managed by ACI

Clinical Research Support

• Diligence on pre-IND compounds
• Medical monitoring and safety
• Medical care and support services
• Accrual pattern research
• Case notebook preparation
• Contemporaneous notebook upkeep

Data Analysis

• Database programming and management
• Data coding
• Validation
• Interim analysis and analysis plan
• Archiving
  

The nationwide ACI networks are coordinated and centrally managed by the ACI.

Each network member is bound by a single contract which allows trial sponsors to engage the ACI in multi-center clinical trials through a single contract with the ACI.

Careful oversight by ACI trial monitors and careful selection and training of network members has resulted in outstanding trial compliance, data management, and data reporting.

Use of ACI trial monitors reduces the time burden and maintains the interest of the participating network members, resulting in more data accumulation for the trial sponsors.

Centralization of this monitoring, data capture, and reporting effort results in sustained interest in trials, sustained and rapid accrual rates, and high adherence to trial notebook reporting standards.

ACI is capable of providing comprehensive data analysis.

PO Box 42535
Washington, D.C. 20015
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