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Why it Matters:
Sites enrolling human participants into clinical research studies are required to adhere to the approved Medicare Coverage Analysis (MCA) generated billing plan when services are billed to the participant or their insurance. If billing errors result, the site faces serious consequences, such as federal lawsuits, financial penalties, and the ban of CMS coverage for the site or Investigator. REGUPro can support your site’s MCA compliance and avoid costly and timely delays by creating a comprehensive and thorough analysis.
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Why it Matters:
Robust and accurate source documents are critical for the execution of successful clinical research studies. The information included on the source documents can make or break your site’s data collection. Source document creation is often overlooked by sites, as it is time consuming and burdensome for the research or regulatory coordinator. Inaccurate or incomplete source documents can result in serious deviations such as enrollment errors or incomplete data collection.
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Why it Matters:
Standard Operating Procedures (SOPs) act as an effective catalyst to obtain consistent and quality study results and operational management. In the event of a Sponsor or regulatory audit, the inspector will require copies of your site’s policies. There are many boilerplate SOPs available online, but it is necessary to create and follow SOPs that are customized to your site, that represent and document how it actually functions. REGUPro can review your existing written procedures and identify gaps, or create baseline SOPs and aid in their implementation.
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Why it Matters:
Contract and budget negotiations are commonly the bottleneck of study start up, resulting in expensive delays of weeks or even months. The Sponsor has skilled negotiators protecting their interests, and your site should have the same advantage. REGUPro can navigate communications between site and Sponsor, streamlining the negotiation process and advocating for your site.
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Why it Matters:
From mock audits to Investigator Site File review, our experienced compliance experts can provide a full range of mission-critical services to your research site. We will support your site in designing and implementing effective and efficient quality assurance and control processes, assuring sustainable compliance throughout the life cycle of your studies.
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Why it Matters:
As the industry evolves, more organizations are migrating to electronic technologies. Processes such as eReg, eSource, and eConsent are becoming more common and will eventually be considered standard. Don’t get left behind, start implementing your part 11 compliant electronic solutions now. Whether your site needs assistance implementing a CTMS or onboarding an entire organization onto eReg, REGUPro’s experts have the experience necessary to guide your site through this process.
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Why it Matters:
Eventually, every site will face an inspection. This may come from a regulatory body like the FDA, or in the form of a Sponsor audit. Having an inspector or auditor on site is a stress inducing experience. REGUPro’s specialists have prepared for and executed dozens of FDA and Sponsor audits and understand how to implement effective and efficient inspection plans.
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Why it Matters:
Conducting a risk analysis is the first step in identifying and implementing safeguards that comply with and carry out the standards and implementation specifications in the Security Rule. If your site it a covered entity or a business associate of a covered entity, it is a federal requirement that you maintain and uphold HIPAA security. Recommended annually, REGUPro can help facilitate this time consuming analysis, providing your site with a detailed security risk assessment report.
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Why it Matters:
Once your site receives a warning letter or 483, it is critical to focus all efforts on implementing corrective and preventative measures to ensure effective remediation of observations and quickly develop a robust response. REGUPro’s compliance experts will help your site draft an appropriate response, implement the proposed actions, and support your team through the resolution of the FDA’s observations.
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Why it Matters:
Accelerate site activation and simplify the collection, completion, and finalization of critical regulatory documentation necessary for approval.
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Why it Matters:
Sponsors are continually evaluating and raising their data integrity expectations, causing citations to become increasingly common. Typically starting with a CAPA, REGUPro can help your site plan a series of actions to resolve compliance issues, and most importantly, to prevent further recurrence. Additionally, we will work with your site to develop a plan focusing on the immediate noncompliance and global scope of the compliance issue. After investigating and understanding the issue, the site will be able to present a comprehensive compliance improvement and or risk mitigation plan.
