Moving towards an E-Document culture

Information technology (IT) is playing an important role in today’s fast paced world influencing every facet of our daily lives. And its influence is only set to increase with Prime Minister Modi’s success with the e-governance model in Gujarat set to be scaled up at the national level. Health Minister Harsha Vardhan too has promised transparency and e-governance measures to bring more accountability in all government-citizen interfaces.

The thrust on transparency and accountability is welcomed by the clinical trials sector, which has been protesting the lack of it in the approval process. The sector has witnessed various regulatory reforms in the past one and half years which has led to a slow down in approval of clinical trials.

“An e-document culture will provide real-time access to critical information that will enable business analytics to take actions in a proactive manner, thereby improving quality, data integrity and patient safety.” Hemant Rehani Vice President & Head CDS, Quintiles

This could change if the clinical trial approval system goes online. Recalling recent developments connected to CDSCO and Drug Controller General (India) (DCG(I)) statement Hemant Rehani, Vice President and Head CDS, Quintiles states, “We have seen recent media reports that the DCG(I) intends to introduce e-governance for clinical trial approvals which is very encouraging.”

The intention is good but would mean high levels of digitisation within industry. As Rehani points out, “Besides the regulators, an IT-enabled environment has to be created across the entire clinical research ecosystem, most notably sites. Hospitals and medical institutions also need to invest in technology-enabled solutions particularly in maintaining health records.”

Is the industry ready? Creating and maintaining such an IT-enable environment has many benefits. Given the volume and sensitivity of the data involved in clinical research, the ability to maintain data integrity and quality is a prime consideration. Inter-operability of systems and standards is also important as clinical research deals with data coming in from different sources, across different platforms and geographies. Rehani briefs, “The most important aspect is that technology needs to help, improve patient safety and outcomes, and deliver therapeutic benefits that are cost effective, faster and more efficacious.”

Tech savvy approach

“I think it is absolutely essential to encourage an e-document culture. It drives efficiency, security and traceability.” Nimita Limaye Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services

The pharma sector is among the most highly regulated sectors, with documentation mandatory to at every step of the regulatory process. Giving an example, Nimita Limaye, Vice President, CDM, Medical Writing and Risk Based Monitoring, Tata Consultancy Services highlights, “Audit trails are critical in a highly regulated industry such as the pharma industry. Electronic trial master files (eTMFs) provide real-time and secure access to clinical documentation to sites across the globe through the entire life-cycle of the trial. This allows for seamless collaboration, higher levels of compliance and documentation quality facilitating auditor review and submission readiness of documents, in alignment with the DIA’s TMF Reference Model.”

“A good Data Management System (DMS) should have uncompromised regulatory compliance. Therefore the benefits would be far reaching for any CRO in terms of security, accountability and tractability of data.” Apurva Shah Group Managing Director, Veeda CRO

Apurva Shah, Group Managing Director, Veeda CRO opines, “A good Data Management System (DMS) should have uncompromised regulatory compliance. Therefore the benefits would be far reaching for any CRO in terms of security, accountability and tractability of data. This would help during sponsor and regulatory audits. It would be a very good way of showcasing the quality of systems and processes.”

“CROs should definitely encourage an e-document culture. e-documents help in ensuring uniformity of process and standards, ease of use and lower costs.” Anita Tripathy President, India, inVentiv international Pharma Services

Regulatory authorities like US FDA and UK MHRA have initiated and begun to accept e-signatures for better transparency in the approval process. Commenting on the e-signature move, Anita Tripathy, President, India, inVentiv international Pharma Services says, “CROs should definitely encourage an e-document culture. e-documents help in ensuring uniformity of process and standards, ease of use and lower costs.”

Underlining the significance of e-signature culture in CRO industry, Rehani says, “An e-document culture will provide real-time access to critical information that will enable business analytics to take actions in a proactive manner, thereby improving quality, data integrity and patient safety. It will not just provide transparency and accountability but it will also help in streamlining the clinical trial approval process and eliminating the need for intermediaries.”

Lack of awareness

The biopharma industry is quite sophisticated and advanced in its adoption of technology at manufacturing sites. But the challenge is at the regulatory end as they are still not geared up to support complete digitisation. Regulators in India are well aware of the benefits of going digital and the advancements in e-documentation that their global counterparts have made. Therefore industry observers hope it will not be long before they invest in and adopt technology to make the clinical research process more efficient.

“Since all regulatory agencies are not equipped to handle electronic data, running the process of e-submission and paper submission in parallel is not a cost effective and efficient option.” Dr Renu Razdan Vice Chairman, ACRO India

Currently CROs and pharma companies in India are caught between regulators with different levels of digitisation. Dr Renu Razdan, Vice Chairman, ACRO India points out, “Since all regulatory agencies are not equipped to handle electronic data, running the process of e-submission and paper submission in parallel is not a cost effective and efficient option.” She continues, “If we move completely to next generation technologies for e-documentation and e-submissions, it will be easy and beneficial for all organisations. It will also help in standardising the process of submission to regulatory authorities.”

Bringing in a paperless culture

There is still a lot of uncertainty in the industry around using eTMFs. While a paperless environment is desirable, companies are taking a conservative approach towards eTMF implementation. As Shah highlights, “Using eTMF is a culture change; we need to be internally ready with processes to be able to switch to eTMFs.”

If the result is beneficial in both the short as well as long term, why are companies still hesitant to switch to the new processes? Shah probably reflects many of his peers when he replies, “We need to assess the readiness of the existing IT infrastructure. The element of reluctance comes mainly from the challenges involved in migration to new technologies and which could in turn lead to technical risks, unpredictable costs, scheduling concerns and skills and culture issues.”

There seems to be general consensus that the complex nature of the industry adds another dimension to such decisions. Explaining this slower than desired pace of change, Rehani says, “As an industry we are traditionally risk-averse and moderate risk takers. This is primarily due to the highly regulated environment we operate in, which is justifiable due to issues like patient safety and confidentiality. Therefore there is a guarded approach to adopting next generation technologies.”

Size also plays a crucial role in such decisions. As Tripathy says, “Smaller firms have concerns over the costs of implementing a high end technology enabled solution. The second stumbling block is usually the lack of in-house expertise. However, these concerns can be alleviated by moving forward with an experienced partner with a proven track record and with an available IT infrastructure. These technologies can reduce the cost, improve the cycle times significantly and increase the ease of use.”

The paper vs electronic debate

Indian CROs use both paper and electronic documentation which is mainly driven by regulatory requirements. The industry feels that implementation of digitisation initiatives with e-governance measures can only help bring better transparency to the system. Rehani analyses, “We need a strong e-governance structure within the regulatory structure to facilitate and enable an e-document culture. For historical reasons, the inclination of the Indian regulators towards paper-based communication is high. CROs have trusted paper-based communication with the regulators although the preference is to go electronic.”

“Indian CROs prefer using electronic data for accuracy and reliability. However, Indian regulatory bodies prefer data in hard copy format,” informs Shah.

A few big CROs/pharma companies like Pfizer, Novartis and Boehringer Ingelheim, etc. have switched to and adopted efficient IT enabled technologies (ie; eTMF) across their global operations. But across the industry, there is still huge scope to adopt these technologies to streamline the processes.

Limaye strongly says, “I think it is absolutely essential to encourage an e-document culture. It drives efficiency, security and traceability.” According to her, the solution needs to be evaluated on parameters like whether it is effectively auditable. user friendly. Costs, integration with existing systems, regulatory compliance, data security, training and help desk support, set up time, scalability, data security, archiving options, flexibility to upgrade based on regulatory changes, etc are other considerations, she adds.

Risks vs benefits

Opportunities and challenges are integral aspects of growth. Certainly IT implementation in across the clinical trials sector will enhance capabilities, but companies will have to deal with concerns like the cost of implementation and skilled manpower, which seem to be the main challenges while adopting IT-enabled solutions.

Attitudes are changing, but slowly. Commenting on this aspect, Renu predicts, “Indian CROs are now transforming to e-submission and documentation wherever accepted. However, there is a long way to shift to e-submission and documentation which requires adaptation of new technologies and trained manpower.”

But solutions also exist. Limaye suggests, “Typical challenges involve in creating IT enabled environment; awareness, investment, change management and rapidly evolving regulations. A private cloud with a multi-tenant architecture enables pharma companies to keep up with frequent upgrades, enhancements and regulatory changes in a cost effective manner.”

“Any CRO is at the mercy of what a sponsor’s auditor is asking for. It is mainly about getting beyond the paper culture. Although the FDA and other regulatory agencies have defined the requirements for electronic document and record systems that store clinical trial essential documents, no government agency has defined how eTMF content should be classified, or the standards for meta data that may used in content indexing, or the electronic format(s) that should be used to model, store or exchange eTMF data. As a result of the lack of a standard to represent eTMF content, eTMF information interoperability and content exchange between systems and applications is inefficient,” shares Shah.

It is important for companies to evaluate their financial resources, ability to orchestrate change and in-house technical expertise. There are costs and efforts associated with changing internal business processes, on-going training for internal resources to keep them updated on new specifications and standards and maintenance and support of the technology. This helps in mitigating the risks to a great extent. The bottom line is that while it does cost to go digital, not doing so may turn out to be more costly in the long run. “For instance, 25 per cent of RTF (refusal to file) from FDA is due to wrong eCTDs. It is important to appropriately train resources on usage of next generation technologies,” sums up Tripathy.

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