Regulatory Affairs

With Pharmaceutical companies cutting costs and demanding optimized regulatory processes, Regulatory departments are faced with the challenge of developing systems and procedures for monitoring and enforcing regulations as defined by the companies themselves and external regulatory authorities such as FDA.

Additionally, FDA and EMEA are cracking down on pharmaceutical companies to ensure compliance with regulations surrounding software solutions that replace manual or paper-based processes. With this increased pressure, the challenges faced by regulatory departments are even greater than before. With the growing need to comply with FDA’s Electronic Records/Electronic Signatures Rule (21 CFR Part 11), companies are investing heavily into training employees, hiring auditors and defining processes ensuring that systems and solutions comply with this rule. Audits and remediation plans based on audits is another threat that pharmaceutical companies are facing on a constant basis.

With constant mergers and acquisitions in the pharmaceutical domain, regulatory departments are confronted with problems in standardizing and enforcing regulations. Having disparate systems also accentuates the problem as no central source exists to track and report on compliance of documents, clinical trial results, approvals and labels related to products. This leads to inefficient processes and inconsistent enforcement of regulations.

Ishi can help regulatory departments in

• defining, designing & building validated systems that comply with FDA regulations
• defining processes that comply with corporate and regulatory body regulations
• designing & building data warehouses to consolidate and centralize regulatory data
• designing & implementing management dashboards
• designing & building business intelligence solutions such as ad-hoc reporting & data mining solutions

Research & Development

With higher demands to release drugs that cure, reduce and eliminate diseases, pharmaceutical companies are faced with the challenges of reducing the time-to-market of drugs while ensuring a high quality product that complies with safety guidelines set-forth by the industry.

Drug Discovery can take anywhere from 8-12 years. Every pharmaceutical company is looking at reducing this time while ensuring that the public has access to newer and better drugs with fewer side effects. With such long cycles, the business, lead scientists and stakeholders need a way to track and monitor the progress of drugs in various stages. Visibility into drug pipelines is a challenge that pharmaceutical companies are facing. This problem is accentuated with the advent of off-shore research firms and pharmaceutical strategies to outsource part of the research to independent researchers.

With these strategies of outsourcing and off-shoring, drug safety, drug research standards, drug discovery progress, conducting & verifying clinical trials and clinical trial result consolidation, validation & reporting are additional problems companies are encountering. Centralizing this data and being able to analyze and report off this data will benefit scientists and the business to make better decisions on research budgets.

Ishi has helped pharmaceutical clients by designing and building systems and solutions that can alleviate these issues. We have provided solutions in the drug discovery and data management areas that help clients gain control over their pipelines & drug discovery phases while providing a means for decision making.

Safety & Pharmacovigilance

Drug safety and reporting is an ever increasing need faced by all Pharmaceutical companies. Regulators such as FDA and EMEA are stricter in ensuring that Pharmaceutical companies adhere to specified guidelines and regulations revolving around drug safety requirements.

With the increased pressure that regulators are applying on companies, business managers are being forced to streamline the reporting process and ensure that safety reports are processed in a timely manner. Compliance groups and Business Managers are demanding clear visibility into the process and performance metrics. Failure to adhere to regulations can lead to pharmaceutical companies being fined in millions of dollars.

Additionally, regulators are enforcing the adoption of electronic submissions mechanisms and efforts like ICH are recommending the harmonization of Adverse Event Reporting, pharmaceutical companies are seeing the need to alter their current processes and systems to adhere to these standards. EMEA is already forcing European regulators to submit Adverse Event reports electronically to pharmaceutical companies in E2B format.

With the increase in drug safety requirements, Pharmaceutical companies are facing the risk of class actions which can not only cost them millions in settlement but affect their overall brand leading to far higher losses. Postapproval drug withdrawal is the worst possible scenario a company can run into. Such a scenario can have a snowball effect that can lead to:

• expenditure in millions to recall the drug
• millions in class actions
• massive expenditure to restore brand
• scrutiny from the press and public on clinical trial standards and safety of other drugs from the company

Multiple acquisitions and mergers in the pharmaceutical domain are also leading to the business having to deal with integration of disparate systems and coming up with a unified system. Having no unified system can lead to other problems like:

• no central location for tracking all the adverse event reports being reported for all the products
• no unified interface for receiving adverse event reports from partners, regulators, local sites, call centers etc
• integration of paper based processing with automated systems
• no central data dictionary to maintain and track drugs as they are released
• higher costs to maintain these systems
• data loss and data inconsistencies across systems
• manual processing leading to higher operating costs

With all these problems being faced in the Safety space, pharmaceutical companies need to assure the regulators and public alike that drug safety should not be a concern and that significant steps are being taken to ensure drug safety. For this to happen, frameworks need to be developed to receive, process, report and analyze adverse event data in an unified manner that adheres to standards and regulations laid down by the regulators.

Ishi can help pharmaceutical clients build these frameworks, systems and solutions through its Business Intelligence & Data Warehousing, Business Integration, Enterprise Architecture and Enterprise Application solutions.

Learn more about our Life Sciences Solutions