Henrik Nakskov, Director and Founding Partner
Among the many risks that pharma and biotech executives sweat over every day, data integrity issues have risen to the top of the list in recent years. It is evident from regulatory actions worldwide that the lack of data integrity can adversely impact manufacturers, stakeholders, and, more importantly, patients who consume the drugs.
But why is data integrity so important?
Industry reports indicate three key reasons: firstly, regulatory agencies and the pharmaceutical industry need accurate and reliable data to ensure the safety, efficacy, and quality of a product. Secondly, data integrity is crucial to guarantee trust between the industry and regulatory agencies. And lastly, regulatory agencies cannot repeatedly audit companies to inspect every part of the drug development process.
To that end, a growing number of biotech and pharmaceutical companies are turning to the most robust data management tools to achieve and maintain data integrity and compliance. But just having the technology will not solve the problem unless combined with a detailed data integrity plan. This calls for a partner who can help determine the best path forward, and that is where Clinical Information Management Support (CIMS), an expert clinical data integration company in the pharmaceutical sector, comes into the picture.
“Decisions based upon data with poor quality are the precursors for mismanagement. We offer assistance as well as innovative solutions to help pharma companies address the issues of information management in clinical drug development,” says Henrik Nakskov, the founding partner and director of CIMS. “We focus on helping our clients utilise the growing wave of data to their advantage, increasing their business revenue.”
In clinical trials, the challenge of ensuring data integrity is not just limited to economic parameters but also factors such as time and complexity. The cost is often driven by a single data element out of a larger amount, where the single data element is crucial for projects to meet their deadline. If data elements are checked in detail with a logistical methodology, it is possible to parallel process the different data in different data flows from each specific source. To that end, CIMS combines supply chain management (SCM) with information management and facilitates continuous reassessment—in the form of Kaizen learning. This approach leveraged by CIMS enables pharmaceutical firms to ensure the highest standards of quality and compliance in their clinical development. CIMS’ services are centred around data, wherein it supports specialist, in-depth, and cross functions in the drug development space. The company focuses on delivering holistic consultation services to its clients, taking into account the entire value chain of information management, IT, and quality management.
Ensuring Data Integrity—All the Way
In the pharmaceutical industry, there are certain regulatory requirements associated with data and information management, which dictate the data owner must always be accountable for traceability in all aspects. Nakskov mentions that this often leads to an imbalance in the drug development cycle.
“Information itself is not a tangible physical commodity, and hence, information management is a challenging task. It requires insight gained through solid educational background and long-term experience,” he adds. However, companies often forget to balance the scales between innovation and regulation. As certified lead auditors, CIMS is trying to bridge this disparity using a unique approach that is critical for data integrity. CIMS’ approach revolves around three main concepts: an ISO 9001:2015 inspired risk-based thinking, information supply chain management (ISCM), and 3*T (Truth-Trust-Traceability). These principles ensure that data is always accurate, validated, and verifiable. Leveraging the approach, CIMS helps its clients use technology and data to their advantage; thus, bridging the gap between data growth, information management, process security, and quality throughout the information supply chain.
CIMS’ Three-Pronged Approach
CIMS incorporates risk-based thinking into its solutions and sets data integrity as a goal for its clients’ services and development
The robustness of data and information is the centre point of any regulation and directive, which requires a robust quality management system (QMS). ISO9001 has—in its latest update from 2015—a changed perspective from standard operating procedures and predictability towards risk-based thinking, which ensures the foundation for data-driven decision are embedded into the QMS. CIMS incorporates risk-based thinking into its solutions and sets data integrity as a goal for its clients’ services and development. Furthermore, using SCM theories such as information logistics, information supply chain management, and data intelligence, CIMS ascertains stakeholder and information flows and establishes the foundations for utilising collective review and cross functions ownership.
But it is CIMS’ 3*T perspective questioning aspect that makes all the difference. Today, regulations, directives, and guidelines focus on ensuring data integrity as the foundation for conducting drug development. While system integrity remains significant, the success lies in handling and preserving data such that it becomes a reflection of the truth and is traceable throughout its life circle. The 3*T can be used as a remarkably simple ‘questioning tool’ which gives a measurement of the level of data integrity. “The ‘Truth’ aspect identifies if the data is a reflection of the occurrences and events under which it was captured. ‘Trust’ ensures that any change, conversion, or activity with data, is validated and verifiable. And, ‘Traceability’ talks about tracking the data both upstream and downstream without any ambiguity,” explains Nakskov.
CIMS leverages five sets of standardised tools for data exchange and processing based on these three main concepts. These toolboxes are designed around five multifaceted regulatory operations, including vendor management, data processes, information management, clinical processes, and audits QA/QC. “We are instituting a whole new process in the preclinical and clinical space, wherein, we enable the clients to optimise their own processes,” says Nakskov.
In fact, clients that have worked with CIMS have witnessed over 50 percent reduction in their trial execution time on selected KPIs.
A Practical and Risk-based Framework
Besides securing data integrity, CIMS also offers stand-alone services such as QMS audits, STAT audits, advanced analytics, change management, post-merger integration, lean process development, and project management. In addition, CIMS also helps pharma organisations to implement Dashboards and achieve significant KPI boosts.
“Information itself is not a tangible physical commodity, and hence, information management is a challenging task. It requires insight gained through solid educational background and long-term experience”
In the last decade, the firm has helped several pharma firms address information management challenges in clinical drug development and achieve exceptional data integrity. To illustrate this aspect, Nakskov cites a client success story involving a firm that wanted to reduce their development time after synopsis to ‘First Patient First Visit.’ However, they had an issue; their protocol development was time-consuming and associated with too many review rounds and coordination. Moreover, the protocols were relatively large, reflecting the indication, and the data collection was enormous—both in numbers and complexity. Even after numerous review rounds, the protocols had errors in spellings, failure references, and other inaccuracies. CIMS built the client an XML-based protocol for data selection from previous trials in the same indication as the foundation, allowing the medical staff and statistical staff to focus on the specific endpoints data. The new review was only focused upon the changes made in the previous trial protocol. This helped the client significantly lessen the study timeline.
Building a Better Future
Such success stories have only propelled CIMS to significant heights in the pharmaceutical sector. Its position is further cemented by the fact that CIMS is one of the very few lead auditors with a data science background within the pharma industry. Another notable aspect of CIMS that has played a significant role in its continued success is its philosophy. “There is a Danish philosopher, Søren Kierkegaard, who once said, ‘If one is truly to succeed in leading a person to a specific place, one must first and foremost take care to find him where he is and begin there.’ This is the very principle we follow at CIMS,” states Nakskov. “We go and meet our clients where they are rather than imposing our perspective on them. We help them assess their strengths and shortcomings, and thus, find the right solution that best fits their needs.”
The company is currently developing new data auditing tools that will help clients enhance their compliance strategies further significantly. Especially in today’s unprecedented COVID-19 times, CIMS is seamlessly adapting its operations to accommodate remote work. Moving ahead on their path of success, the company will focus on enhancing its clients’ capabilities. “We also have plans to expand into a full-fledged medical device production company,” informs Nakskov.
Data is the bedrock of a pharmaceutical product’s pathway to market, and the consequences of data failures can be immense. With a partner like CIMS that is committed to ensuring data integrity all the way, pharma businesses can finally breathe a sigh of relief.