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Let Kymanox Help You Solve the 5 Most Common Issues in a GCP Study

Below are 5 of the Most Common Issues in a GCP Study, and How We Solve Them:

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1. Poor oversight of third-party vendors and suppliers (e.g., materials, medical devices).

At Kymanox, we perform assessments to help your company determine when third-party audits are necessary. When indicated, our targeted teams perform detailed, on-site third-party vendor audits that ensure your partners are abiding by your agreed terms, as well as the many applicable regulations. As your company is ultimately responsible for their compliance (or lack thereof), these audits ensure that your studies are safe and effective and that your company is fully compliant.

2. Lack of management of Product Complaints and Adverse Events.

Critical to clinical studies, the Product Complaint and Adverse Events requirements can often vary depending on the context of the reports. Management of this data can be difficult and is subject to strict reporting requirements per the FDA. Kymanox helps companies structure their systems to not only be compliant, but to be efficient and cost-effective.

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3. Lack of reliable, accurate and adequate source documentation (data integrity).

Data integrity issues are frequently cited by the FDA and can even lead to permanent debarment by individual clinical investigators. Kymanox can assist in implementing clear procedures to ensure the highest level of data integrity, minimizing unclear, poorly documented data and by greatly reducing the chance of erroneous or falsified entries.

4. Inadequate investigator and investigation staff training.

Even the best SOPs are worthless without proper implementation and compliance, which cannot be achieved without company-specific training. At Kymanox, we specialize in both train-the-trainer sessions and company-wide educational events that are customized and documented to fit your requirements. Our SMEs have presented at nearly all major industry conferences and includes prestigious teaching fellows and prior academic faculty, employing effective and motivational training techniques.

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5. Protocol deviations (failure to follow protocol and failure to document the deviation).

Even seemingly minor protocol deviations in a clinical study can have major implications to the study results, leading to swift study rejection by the FDA. Kymanox can review your protocols prior to study commencement, leveraging our expertise to anticipate potential study hurdles, minimizing the need for protocol deviations. Additionally, Kymanox can assist with authoring Deviation Reports based on past data to anticipate study impact and justify our best-practices recommendations, while properly documenting the data for the rationale.

Kymanox can help you solve all of these problems.

Overall, Kymanox can help ensure cost-effective, solution-based approaches to ensure that your clinical studies are not only compliant, but successful. We employ responsive SME-lead teams that are rich in knowledge and experience but lean on costs. Our expertsí experience spans all aspects of the life sciences- including biomedical research, academic faculty, executive-level pharmaceutical quality leaders and other industry leaders.

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training for Good Documentation Practices.

Kymanox provides turn-key global Quality Audit Services using our ASQ certified personnel for biologic, drug, and device firms.
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