Animal Health Products Development
Companies seeking to develop animal health products face complex issues involving experimental design, method development, investigator and site selection, trial oversight, and reporting of results. The challenges involved in conducting trials in companion and production animals require in-depth knowledge of the animal health industry and the processes leading to registration of animal health products. BSI has the expertise the animal health industry needs to facilitate product development.
BSI is an Affiliate Member of the Animal Health Institute
Study Design and Protocol Development
Robust study designs, clearly written, comprehensive protocols, and appropriate data capture forms are your keys to successful study outcomes. BSI designs studies and writes protocols which focus on these critical objectives. Studies may be designed based on concepts provided by the sponsor, regulatory agency guidance, or information obtained from literature or scientific sources. Data capture forms are designed to accurately capture the study results and to assure data validity. BSI can print the protocol and forms and distribute them to investigator sites, as well as provide training on both.
Analytical and Bioanalytical Method Development
Timely development and validation of accurate and specific analytical and bioanalytical methods are essential for efficient product development. BSI understands that sensitivity, ruggedness, and throughput are important practical considerations. We have the expertise to assist with development and validation of analytical and bioanalytical methods for stability studies, dose confirmation assays, and determination of drug and metabolite concentrations in biological matrices. Services we provide include identification and evaluation of available methods, method development needs assessment, identification and qualification of appropriate analytical and bioanalytical laboratories, RFP preparation and proposal evaluation, protocol and data review, and monitoring of method development and validation projects.
Drug product stability results are often rate limiting components (or time-critical elements) of NADA and ANADA submissions. BSI can advise on stability study and stability commitment requirements, identify and evaluate stability indicating methods of analysis, prepare stability protocols, identify and qualify appropriate stability study sites, prepare RFPs and evaluate proposals, monitor studies, and evaluate and summarize study results.
The monitoring function is vital to the timely progress and accurate implementation of your protocol. BSI can provide all-inclusive or site-specific study monitoring services depending on your needs. Knowledgeable monitors will handle the pre-trial, in-process, and close-out monitoring visits as well as the associated tasks involved in trial implementation. BSI monitors customarily develop study notebooks, provide training to investigators and their staff, interpret the protocol for study personnel, facilitate resolution of scientific and regulatory issues that arise, including adverse events, and review data during and at the conclusion of the study. Typically, the monitor also provides the sponsor with information for drug shipment, summarizes drug and animal accountability for the sponsor, and coordinates the archival of study and monitor files. The monitor will review the study report for completeness and accuracy. Consistent with CVM and VICH guidelines, the monitor can also be the joint or sole author of reports of clinical investigations.
Study and Project Management Services
A project manager assigned to each study, often the lead monitor, oversees and reports the status of study activities and coordinates project meetings. In addition, BSI can provide assistance with the numerous details within your project ranging from investigator and study director recruitment and handling investigator payments to qualification and selection of contract laboratories. Investigators and study directors will be chosen based on study needs and their ability to meet regulatory requirements. In conjunction with the sponsor, BSI will request the study budget, negotiate to achieve satisfactory terms, develop a study agreement, and request and track or handle study payments. Additionally, BSI will locate adequate and well-maintained facilities for the trial. BSI also can provide a scientific and regulatory assessment of investigators, sites, or other external services organizations tentatively selected by sponsors.
Statistical Analysis and Data Management
Study designs must be statistically sound. BSI biostatisticians provide assistance with protocol development by performing sample size determinations, formulating appropriate statistical analyses, and writing the statistical analysis plan for the study. We also provide assistance with blinding and randomization procedures.
To make your study data available for analysis, we will design databases and data entry procedures to capture the data from the data capture forms. BSI can also provide programs to screen data for common data inconsistencies or any sponsor initiated query. We provide summary tables, listings, and graphical output for study reports based on sponsor requirements.
Our biostatisticians generate individual study statistical reports and can also provide combined trial statistical analyses.
In conjunction with sponsor QA, BSI develops and implements a QA plan for each study in which it participates, whether GLP- or GCP-regulated. As is essential, BSI’s QAU operates independently of monitoring and study management.
BSI can provide assistance with regulatory requirements and, if desired, will handle communications with the Center for Veterinary Medicine for your project. BSI will prepare or manage development of quality documents for regulatory submission. Documents can be sent to the sponsor for submission, or BSI can submit them on behalf of the sponsor. We also perform quality control reviews of submission documents drafted by sponsors prior to finalization.
For more information on BSI’s Animal Health Product Development services, contact Robbin Koenig
(501) 758-6290 ext. 122 or
