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Industry ExpertiseLife SciencesSafety, Risk & Compliance Management

The Life Sciences industry is one of the most regulated industries in the world. Ensuring compliance is a key focus for all Life Sciences companies. Patient safety is at the center of these regulations and includes adverse event reporting, clinical trial data collection controls, process and system validation, manufacturing quality, laboratory and clinical documentation, and clinical data submissions and review.

In addition, Sales and Marketing activities are subject to various guidelines. Prominent among these are medical, legal and regulatory (MLR) guidelines on promotional material and product labeling; the Sunshine Act and Fair Market Value (FMV) reporting, a part of the Affordable Care Act, which continues be in flux; sample accountability; and the developing social media engagement guidelines among others.

With the constantly changing regulatory landscape, Life Sciences companies need to stay current and compliant, and develop systems to address the regulatory reporting requirements and standards. Trexin can enable Life Sciences companies in the Safety and Compliance areas as follows:

  • Proactively predict or identify the potential for non-compliance, helping avoid compliance risk
  • Help develop enabling systems in support of standards such as IDMP and dictionaries such as MedDRA and WHO-DD.
  • Leverage business intelligence and advanced analytics, support pharmacovigilance and adverse event reporting and analytics
  • Dashboard and enhancements of systems to support commercial compliance including aggregate spend (Open Payments) reporting and analytics
  • Plan and execute testing and validation as per 21CFR11 standards
  • Develop a Cybersecurity program to manage information security threats

Trexin brings its technology strategy, solution delivery, advanced analytics, business intelligence, data management, cybersecurity and governance capabilities to help address the key challenges and leverage new opportunities for Life Sciences companies.

Help section

Help me support Open Payments & EFPIA compliance

The Sunshine Act (Open Payments) has been in force for a few years now. As part of the implementation of the requirements of the Sunshine Act, Life Sciences companies have established new systems and processes to support reporting of the exchange of value to reportable healthcare entities. This regulation is now being adopted worldwide with the European EPFIA regulation being introduced. The rules and the level of data reported is different for these regulations and Life Sciences companies are developing point solutions to address these regulations.

Trexin can help develop a closed loop compliance system aided by advanced analytics to provide better visibility into compliance issues; better predictability and early warnings of any potential for non-compliance, approaching spend limits or thresholds; and implement additional capabilities such as exception reporting, benchmarking, identification of excluded entities (OIG blacklists) or dispute resolution systems. Trexin can also review your existing solution to evaluate reuse for global compliance or help enhance the solution to support advanced analytics capabilities and platform extensibility.

Areas of Expertise:

  • Open Payments
  • Sunshine Act
  • Aggregate Spend Reporting
  • EFPIA,
  • Compliance Dashboard

Help me perform a cybersecurity assessment

Information system breaches continue to rise and Life Sciences companies are not immune to this issue. The potential loss to a large Life Sciences company can run into millions of dollars (if not billions depending on size and liability) and having a strong Cybersecurity program is critical to minimizing risks and reducing liability.

Trexin can perform a Cybersecurity assessment for your company and propose specific recommendations, leveraging our “defense in depth” strategy. It is becoming increasingly critical and urgent for Life Sciences companies to not only protect their assets but also reduce costs and down times to resolve issues after a potential attack.

Areas of Expertise:

  • Cybersecurity Assessment
  • Cybersecurity Implementation

Help me implement analytics for pharmacovigilance

Patient safety is at the core of most regulatory compliance guidelines and pharmacovigilance (PV) is a key driver of patient safety. The advent of the IDMP standard and the leverage of modern data architectures and advanced analytics can enable better analysis of pharmacovigilance and safety data. This can include better cross study analysis of safety trends and more efficient reporting and analytics of safety data by MedDRA SMQs and IDMP hierarchies.

Areas of Expertise:

  • Pharmacovigilance Analytics
  • Modern PV Analytics Architectures
  • IDMP standards

Help me lead my validation testing efforts

Life Sciences companies are all too familiar with validation testing requirements driven by 21CFR Part 11 regulations. Too often, these efforts are not planned or executed efficiently resulting in project delays and stakeholder dissatisfaction. Trexin can provide leadership in the management of your validation testing efforts for IT systems, working with your project and testing partners to more efficiently plan and conduct your validation testing efforts. Trexin can also provide program/project management to support your validation testing or compliance efforts.

Areas of Expertise:

  • Validation Testing
  • 21 CFR Part 11
  • Program and Project Management
  • Agile
  • Risk based Testing
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