This is IT

Pharmaceutical firms not only have to create breakthrough medicines – they have to do so whilst remaining compliant to changeable legislation. Abiding by the rules on a global scale is critical – so, can it be made easier? Stuart Ward tells us why he thinks it can…

The need to follow procedures is ingrained into scientists from the genesis of their training and continues throughout their careers. The regulations also define standards and processes that must be followed to ensure any data captured is complete and provides a true reflection of what occurred during the investigation. The need to follow procedures is ingrained into scientists from the genesis of their training and continues throughout their careers. The regulations also define standards and processes that must be followed to ensure any data captured is complete and provides a true reflection of what occurred during the investigation.

The aim of all of this? To provide a high degree of confidence in the decisions and conclusions being made during the drug discovery process.

Validating research, experiments and results is a vital part of the drug discovery process. Authorities like the European Medicines Agency (EMA), the Food & Drug Administration (FDA) in the USA, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, need to be sure that drugs going to market are safe for public consumption and also determine whether the known risks or side effects associated with a drug are acceptable. To do this, they set various standards which need to be met before drugs can be sold in the country and/or region they are responsible for.

Since pharmaceutical organisations want to maximise their revenues from each drug produced, they need to ensure that they, and any other parties working with them during the research and development process, comply with the standards set out in regions and countries around the world. This includes the need to perform work and studies in many different countries to ensure compliance. The end result is a global compliance challenge – where multiple standards must be adopted simultaneously to ensure maximised revenues from any single drug.

To complicate matter further, the regulations can, and do, change. In the past 50 years, the European Commission has introduced nearly 30 pieces of pharmaceutical legislation to help regulate and standardise the way in which systems, processes and research are conducted. This means that pharmaceutical organisations must consistently benchmark their work to new industry standards to ensure that they remain compliant.

Thou shalt remain compliant

One of the reasons for the changing regulations is to reduce the occurrence of data integrity issues. There have been numerous examples of drugs, marketed as a treatment in good faith, showing serious issues once used in the wider population. Investigations have shown that in some cases, the cause of these issues – both accidental and malicious – have been related to data integrity and organisations failing to maintain a complete data records. The more serious issues surrounding data integrity have led to the suspension of medicine applications, and can impact both the research firm involved and those that outsource their work to contact research organisations.

The wide range of data being captured, combined with companies operating globally and needing to meet a large number of regulations, all whilst maintaining efficiency, creates a complex challenge for organisations. Thankfully, there are systems and software solutions available that can help pharmaceutical companies deliver medicines faster – but beware, not all of these systems are capable of being validated for use in GxP (Good Practice) environments. Picking the right solution that meets the functional requirements and ensures compliance is vital to encourage good lab practices and to reinforce organisational due diligence by guaranteeing quality and safety.

Compliance and efficiency

As organisations increasingly look for operational strategies that can streamline the drug discovery process, more and more are turning to contract research organisations (CROs). This often involves working with organisations across borders, whilst still needing to ensure all parties are compliant with local authorities and regulations. However, few organisations consider integrating validated software and data management systems into their outsourcing arrangements.

Many organisations are apprehensive about allowing external parties into their network through a corporate firewall. In most cases, it’s simply not allowed at all – so new approaches and technologies need to be introduced to provide the benefits of collaborative working without needlessly opening up systems. The cloud offers a great opportunity to do this by providing the infrastructure and technology on an on-demand basis that can be spun up and down as required. However, this can just create another data silo for IT to manage. It’s critical for any system to capture data in a way which allows the transfer of verified and accepted data into corporate systems for further internal use and development.

Implementing data management software where industry regulations and good practices can be embedded into the data capture process, coupled with data input only from authorised and approved individuals, will boost confidence further when working with a CRO that can be based thousands of miles away. It can help ensure that the same rigor applied by a pharmaceutical/biotech company is also applied by an outsourced partner.

Implementing data management systems that automatically capture essential data for inspections – such as those conducted by the FDA and EMA – will streamline operations, ensure compliance and add real value to an organisation’s overall productivity. The use of a platform, ideally with fully integrated functionality that covers many of the traditional systems in one end-to-end platform, is vital for organisations that need to efficiently capture, present and analyse data whilst meeting the GxP regulations.

Author: Stuart Ward, Head of Business Analysis at IDBS