Fostering steady advances in data operations: FSP partnerships can spur and support change

5 min

When we discuss innovation in clinical trials, it’s easy to think first of technologies involving digital health or evolving tools such as augmented intelligence. And these are certainly meaningful advancements.

But for every major improvement in our industry, there have been dozens of smaller innovations along the way. This incremental innovation, which results from the steady, focused efforts of sponsors and their partners, can create real value for biopharma companies.

One example of that value is the challenge of data standardization as a barrier breaker to enable transformative new technologies. These are technologies that can radically simplify or reimagine complex processes to dramatically reduce cycle timelines and variability across the clinical trial ecosystem.


Incremental innovation in action

Increasingly, global regulatory authorities are focusing on common standards for submissions. This includes most notably the FDA, which—since 2014— has specified formats for electronic submissions and can reject eCTD submissions for non-compliance.

Ideally, all trial data would be collected in a standardized format. But studies involve a massive  and rapidly expanding volume of data, much of which is collected, unavoidably, in disparate legacy formats. Our industry is working toward uniformity, but in the interim sponsors need incremental ways to harmonize data, regardless of the source.

Recently, Parexel partnered with a large biopharma company to do just that. To enable interoperability and automation in our client’s data management processes, we helped implement CDISC standards for regulatory data submissions (SDTM) and analysis data (ADaM). First, we developed an ADaM Reviewer’s Guide template, based on CDISC/PhUSE guidance to comply with evolving regulatory requirements. With that standard in place, we then created SDTM mapping for our client’s Rave EDC platform. This mapping eliminated manual transformation and sped the delivery of data to analysis teams.


Making gains and moving forward

For this engagement, we focused on data transformation activities that include SDTM specification writing and SDTM dataset programming. Thanks to incremental change, we:

  • Improved operational efficiency by 40 percent.
  • Reduced timelines by 50 percent, from three months to just six weeks in the case of complicated immuno-oncology designs.

Since our initial project, we’ve expanded our work to include standards development for most of our client’s immuno-oncology development portfolio, which includes the organization’s highest priority assets. Our client has also asked us to create standards for electronic case report forms to accommodate legacy systems integrated into the existing R&D architecture.


Streamlining through partnership

When addressing the many challenges of clinical development, it can be helpful to have a partner in your corner. That’s one benefit of working with a CRO like Parexel. You get an expert and an ally who can offer new perspectives and expertise across the drug development process.

In the FSP model, we form a team matched to your organization’s specific needs. And that gives you the chance to innovate in ways that may not have been evident or possible before. When it comes to data standardization, for example, Parexel can create data standards that map to your internal systems and data lifecycle requirements, as we did for our client’s oncology portfolio.

What’s more, we can provide solutions that use our own systems and processes with your templates. When you opt to use a CRO’s systems, you benefit from your partner’s best practices, wide base of knowledge, and its own ongoing investment in innovation. At Parexel, we’re continually refining and streamlining our approach to data operations, which includes ongoing investment in developing comprehensive tools that eliminate and/or automate repetitive processes in the data lifecycle of a clinical trial:

  • An extensive standards library, which helps simplify and automate the data collection and analysis process. This library speeds study design and stust setup; accelerates data analysis, reporting and visualization, and encourages end-to-end use of standards from protocol development through final study report. It also allows sponsores to reuse metadata across a program and in future studies.
  • A central data platform. By brining every source of data into a single repository that automates mapping, cleans data and exports into SDTM fortmats, we lessen risk by eliminating unnecessary manual transfers. We also reduce complexity by minimizing the number of data-collection tools with which managers must interact.
  • Progressive data cleaning, which eliminates the traditional query management process and makes it possible to easily configure batch queries by patient, site, visit, or other filters. Teams can better prioritize data queries at any time in a study and resolve them more efficiently.
  • A growing, customized archive of global macros. Macros reduce the need for double programming while still ensuring consistent quality output. Solutions are ready sooner and require fewer development hours.

Harness the power of incremental innovation

Today, sponsors are partnering more closely with CROs for data operations solutions and process improvement. It can be difficult to identify opportunities for optimizing data management across a complex data ecosystem, and even if you’ve targeted areas for improvement, implementing department- or enterprise-wide change can require significant effort. Does your organization have the resources, the right expertise, tools and enough flexibility to undertake these kinds of initiatives? Through an FSP collaboration, a CRO partner like Parexel can provide support — and tested technology solutions.

Interested in pursuing this kind of partnership? A few things to consider:

  • An FSP collaboration maximizes the value of the sponsor-CRO relationship but also requires increased levels of trust. For example, to take advantage of a CRO team’s expertise, a sponsor might need to include that team in planning discussions and decision-making for the sponsor’s data strategy.
  • The ideal CRO partner must dedicate teams to the work it does for the organization. This investment encourages creative problem-solving and keeps the CRO team fully engaged in and accountable for the sponsor’s processes. And that creates natural and ongoing opportunities to incrementally innovate on the sponsor’s behalf.
  • Incremental innovation requires patience and a long-term perspective. The FSP model is ideal for implementing moderate, steady change. A committed, consistent CRO partner with a focus on FSP innovation will be invested in making incremental and progressive improvements with you, positively impacting larger processes.

With continuous innovation, your savings and gains accrue over time. These gains are particularly valuable when it comes to data standards and process-intensive core functions of data management, biostatistics and statistical programming. Steady process improvement allows sponsors to reduce costs, shorten timelines, introduce labor-saving tools and help ensure higher quality data. Sponsors that invest in these improvements will be better positioned to take advantage of transformative technologies in the future.

An FSP partnership can be part of that investment. And the right partner will be committed to fostering efficiency — for you and for the patients you both serve.

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