Multi-country, International Efficacy for Biologicals Resulting in Successful Registrations
The client needed data generated within the countries where it would be submitted and additional data for other uses. The challenge is orchestrating successful trials and data collection in areas where infrastructure is less than optimal, the number of trained field researchers is limited, and sample movement into and out of the country is challenging.
INTERNAL vs EXTERNAL HIRING - Funding or Feelings?
The challenge is orchestrating successful trials and data collection with limited agronomic expertise, limited current staff of scientists, a tight timeline, and a lack of direct relation to contract research organizations. The client needed data generated within the USA without lost time. There are many “moving parts” involved in successful regulatory and/or efficacy experiments. Identifying, hiring, and on-boarding new people takes time and field seasons do not wait. Hiring internally also means a commitment to overhead costs during “down time”.
Data for EPA in Crops Not Commercially Produced in the Continental USA?
The client needed data for residue tolerances of a pesticide on papaya and pineapple. The data needed to be generated in the USA. The client wanted to conduct these trials in the USA to avoid import, export, and time delays related to working in other countries and to shorten the timeline to completion. Because the production of pineapples and papaya for the fresh fruit and processing markets have been moved offshore for cheaper labor and out of Hawaii due to limited land resources, there were few production areas available in the USA. To add to the difficulty, the EPA requires temporal or spatial separation between trial locations. Since the opportunities for production were in very limited areas, the separation also became a challenge. Global Ag’s team of scientists worked diligently to design the experiments to overcome all of these challenges.
Tier II & EPA Summary Tables for Submission
The client needed data for measured residue of a pesticide on multiple crops compiled into the required regulatory tables for both the EU and the USA. These tables are complex and time consuming, however the client knew Global Ag could leverage the eStudyTM Software product to expedite this task. To add to the difficulty, the EPA requires a different format from the EU. Global Ag’s team of scientists and Assistant Project Managers worked diligently to to overcome all of these challenges and deliver the needed tables on time.