Laura Jones, Director, Product Management - RIM, ArisGlobal10.03.22
Regulatory teams play an essential role in every stage of bringing a drug or medical device to market. From initial research to regulatory approval, these teams are the common thread of research and development (R&D).
Because of their critical role, regulatory teams should have easy access to all data and evidence an organization generates throughout the R&D process. Unfortunately, most do not. Many companies still rely on legacy technology that siloes data across different pillars. To operate at peak efficiency, regulatory teams need a single source of truth solution to complete their work in each R&D phase.
Because public perception of how quickly treatments should come to market has changed since the start of the COVID-19 pandemic, regulatory teams also face new pressure. They’re expected to contribute to shortening the time between product design, testing, and launch.
Regulatory teams cannot cut corners, but a single source of truth solution can help them work smarter and more efficiently. In the United States, the FDA only approves about 14% of all drugs in clinical trials. This statistic highlights the importance of identifying risks early in the trial process to avoid mistakes. By ensuring compliance, regulatory teams prevent costly delays from affecting their organizations. A meticulous, compliant, and well-documented process increases the FDA's likelihood of approving a drug — and doing so more quickly.
Having a single source of truth helps regulatory teams involved in each stage of the R&D process do their jobs better, offering benefits in several key areas: document compilation, gap identification, submission preparation, and real-time oversight.
The single source of truth also saves teams time searching for the right documentation or translating pre-written reports into the format required by a governing agency. Raw data is easier to format into region-specific requirements, like the Identification of Medicinal Product (IDMP).
Continual access to the most current information across the organization data enables greater regulatory intelligence capabilities through artificial intelligence (AI). Teams can conduct a root cause analysis (RCA) faster, significantly benefiting the clinical team, which relies on its regulatory counterparts to maintain compliance. Otherwise, if clinical teams find themselves noncompliant, they run the risk of delays or rejection from governing bodies evaluating and approving their product.
The benefits of using a single source of truth solution extend beyond the clinical domain into safety and medical affairs. Having easy access to underlying data instead of relying on approved dossier documents opens other avenues of automation for cross-functional purposes. A central regulatory database automates the MedDRA coding of clinical particulars for safety case reporting. A medical affairs team can also access approved product information from the same source more easily, enabling regulatory insight.
Many systems interact throughout a product’s development lifecycle. Because lifecycles aren’t linear, controlling workflows between each functional area and ensuring visibility is vital for supporting efficient R&D processes. Connected systems provide everyone with a unified truth, helping provide consistent data for decision-making, aligning efforts toward the same goal by defining metrics of success, and ensuring data and knowledge don’t become lost within individual silos.
Laura Jones is an industry veteran with 20+ years of Information Systems third-tier experience supporting a wide array of technologies concurrent with Pharmaceutical and Biotechnology Regulatory industry experience. Jones is proficient in R&D technologies and implementation activities related to submission and content management, and has extensive knowledge of global agency guidance/regulations. She has managed various system design and implementation projects for R&D systems, as well as EDMS content management system integration and validation activities.
Because of their critical role, regulatory teams should have easy access to all data and evidence an organization generates throughout the R&D process. Unfortunately, most do not. Many companies still rely on legacy technology that siloes data across different pillars. To operate at peak efficiency, regulatory teams need a single source of truth solution to complete their work in each R&D phase.
Evolving Pressure on Regulatory Teams
Having a single source of truth — a set of data shared across an entire organization — is incredibly important within the life sciences industry. Different teams reference this data throughout a drug or medical device candidate’s lifetime. Regulatory teams increasingly rely on access to data across the organization as they face more challenges than ever, such as limited real-time visibility to data, technical complexities, and continual regulatory changes.Because public perception of how quickly treatments should come to market has changed since the start of the COVID-19 pandemic, regulatory teams also face new pressure. They’re expected to contribute to shortening the time between product design, testing, and launch.
Regulatory teams cannot cut corners, but a single source of truth solution can help them work smarter and more efficiently. In the United States, the FDA only approves about 14% of all drugs in clinical trials. This statistic highlights the importance of identifying risks early in the trial process to avoid mistakes. By ensuring compliance, regulatory teams prevent costly delays from affecting their organizations. A meticulous, compliant, and well-documented process increases the FDA's likelihood of approving a drug — and doing so more quickly.
Having a single source of truth helps regulatory teams involved in each stage of the R&D process do their jobs better, offering benefits in several key areas: document compilation, gap identification, submission preparation, and real-time oversight.
Compiling Documentation
When regulatory teams have visibility into activities within each domain, it becomes easier for them to compile documentation required by different regulatory bodies. For example, pre-existing narrative documents or dossiers can contain outdated information or be missing key figures. A centralized data location allows regulatory teams to pull what they need directly from the source.The single source of truth also saves teams time searching for the right documentation or translating pre-written reports into the format required by a governing agency. Raw data is easier to format into region-specific requirements, like the Identification of Medicinal Product (IDMP).
Identifying Gaps
Needing to manually check data quality is tedious and inefficient. The process ties up valuable human resources and increases the likelihood of human error. Instead of teams working to integrate multiple systems and sources while also tracking and filling necessary changes, a single source of truth solution handles all the heavy lifting, freeing teams to focus on tasks requiring more critical thought. Better insight helps regulatory teams identify, address, and correct hurdles and gaps in data collection during each trial phase. Teams equipped with this solution can mitigate issues earlier in the process before submitting the findings, generating stronger evidence and, eventually, submissions.Preparing Robust Submissions
Direct access to all of an organization’s data enables teams to prepare stronger submissions that will be subject to fewer changes. Fewer change requests often mean a faster approval process. Because single source of truth solutions automatically update with the latest regulatory compliance standards, submissions remain consistent throughout the R&D lifecycle, which regulatory bodies prefer. Submissions with consistent data are less likely to draw scrutiny or raise red flags. Regulatory bodies can also move submissions through the approval process more quickly.Offering Real-Time Oversight
Clinical and regulatory teams need to be in tune with each other along every step of the R&D process. Real-time communication eliminates the need for constant document upload and download. A single source of truth solution provides regulatory teams with the most up-to-date forms and regulations, allowing them the ability to continuously access the most current information.Continual access to the most current information across the organization data enables greater regulatory intelligence capabilities through artificial intelligence (AI). Teams can conduct a root cause analysis (RCA) faster, significantly benefiting the clinical team, which relies on its regulatory counterparts to maintain compliance. Otherwise, if clinical teams find themselves noncompliant, they run the risk of delays or rejection from governing bodies evaluating and approving their product.
The benefits of using a single source of truth solution extend beyond the clinical domain into safety and medical affairs. Having easy access to underlying data instead of relying on approved dossier documents opens other avenues of automation for cross-functional purposes. A central regulatory database automates the MedDRA coding of clinical particulars for safety case reporting. A medical affairs team can also access approved product information from the same source more easily, enabling regulatory insight.
Many systems interact throughout a product’s development lifecycle. Because lifecycles aren’t linear, controlling workflows between each functional area and ensuring visibility is vital for supporting efficient R&D processes. Connected systems provide everyone with a unified truth, helping provide consistent data for decision-making, aligning efforts toward the same goal by defining metrics of success, and ensuring data and knowledge don’t become lost within individual silos.
Laura Jones is an industry veteran with 20+ years of Information Systems third-tier experience supporting a wide array of technologies concurrent with Pharmaceutical and Biotechnology Regulatory industry experience. Jones is proficient in R&D technologies and implementation activities related to submission and content management, and has extensive knowledge of global agency guidance/regulations. She has managed various system design and implementation projects for R&D systems, as well as EDMS content management system integration and validation activities.