Case Studies

Case Study #1

Clinical Trial Case Study in Gastroenterology: Phase II, Safety and Efficacy Scenario: A Phase II NDA trial with 20 sites enrolled 123 patients in four months with outstanding clinical results. The client approached us with a protocol and a list of 16 sites harvested from a well-circulated list of traditional GI investigational research sites historically utilized by large pharma and large CROs. The client had a database selected and needed full-scale study management and monitoring and desired, above all, enrollment within nine months from date we were contacted. Our team

Case Study #2

150 patient, 15 site study with a women’s health indication. Neozene had no prior direct therapeutic experience but relationships with key investigational sites. Originally cast as a pilot and pivotal phase project that needed completion within 12 months, a sponsor decision to seek FDA guidance after the pilot phase resulted in an extension of one year on the project. Neozene leveraged relationships, pivoted resources and enacted several process amendments to ensure no budget amendments were required despite the 12 month study extension. Upon study restart, with proper planning and resourcing,

Case Study #3

Saved sponsor $48K monthly ($1.8MM total) in management and monitoring fees and increased enrollment timelines by 2 months for Phase III HCV study. How did we do it? Initially provided CRO oversight for sponsor lacking necessary volume of internal management and oversight resources. After being tasked with overtaking North America monitoring and management operations, enacted efficiencies to improve study budgeting and timelines. Transferred study (US, CAN only) from large non-performing CRO to Neozene within 30 days of contract award. Re-evaluated enrollment delays by closing non-performing sites and incentivizing accruing sites.

Case Study #4

RUO Transitioning into the IVD Market Neozene was approached by a diagnostics company with a portfolio of Research Use Only (RUO) products. The company’s goal was to have their devices FDA cleared for commercial use in order to take advantage of the emerging market of personalized medicine. Business challenge: The company was not sure of the regulatory requirements that would govern their RUO products in the commercial market. They needed a high level Advisor to help them structure and prepare their Reagent Manufacturing Operations to be in compliance with the

Case Study #5

ISO 13485 CERTIFICATION PREPARATION Neozene was approached by a component manufacturer that supplies to the medical device industry. They were preparing for their first supplier audit from their biggest client and needed to establish a robust Quality Managment System and provide training to personnel that were unfamiliar with the regulations of the medical device industry. They approached us asking for a Quality expert to generate and implement a new ISO 13485-compliant Quality Managment System. Busienss Challenge: The company had little knowledge of the regulations for the medical device industry and

Case Study #6

Business Challenge: The client had been issued a 483 with findings from their FDA inspection requiring immediate response and remediation. Proposed Solution: We sent our QA/RA expert out to spearhead the FDA response project. After thoroughly reviewing the FDA findings, our project leader coordinated with client personnel to form a response team and formulate the response with a corresponding corrective action plan. Results/Value Delivered: The client agreed with all proposed activities including a product recall. The results are ongoing. However, the outcome from this project is that the client asked

Case Study #7

Business Challenge: The client needed expertise in leading the implementation of a UDI-compliant labeling system. Proposed Solution: Neozene proposed that they retain our UDI expert to lead the project and a labeling expert to, under the guidance of the project lead, implement all needed process steps at the client site. Results/Value Delivered: The client agreed with the proposed solution and retained the Neozene UDI labeling experts for the project establishment and implementation of the UDI solution. As a result, the client established a fully compliant labeling process along with the