Challenge

A pharmaceutical company developed an innovative treatment for a chronic eye condition that is a leading cause of blindness. Tight Food and Drug Administration (FDA) deadlines—25 percent shorter than usual for a trial of this size and complexity—made it difficult for the company to complete the regulatory submission materials in time. To help speed the drug to patients, the pharmaceutical company tapped into Accenture’s clinical data management and regulatory services.

Focus on clinical data

The company required additional skills and team members to prepare the materials in time. Accenture managed the regulatory submissions so the company could stay laser focused on the science. We helped the company quickly compile and submit safety and efficacy data in a digital format for three late-stage ophthalmic clinical trials.

Strategy and solution

We collaborated closely with the pharmaceutical company to create a submission strategy to help deliver on an accelerated schedule. We also built a statistical analysis plan for safety and efficacy and checked for study compliance as per CDISC standards.

The fast-track to approval

Within three months, Accenture provided the following clinical data services:

A common electronic format with CDISC compliant conversion standards.

Study data tabulation model (SDTM) compliance validation, where we checked that the study data met CDISC standards.

Analysis data model (ADaM) compliance validation, which generated the data for ISS and ISE.

Pooled two studies for the integrated summary of safety (ISS) and integrated summary of efficacy (ISE) analysis.

Generated 650-plus statistical outputs in support of ISS and ISE.

Medical writing to support the NDA, MAA and 120-day safety update submissions.

Support for labeling updates.

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Evolving along with submission requirements

The submission encountered some hurdles, which the team dealt with smoothly. Part way through the process, the FDA requested that the company include an additional study, and our team quickly adjusted the strategy and processes accordingly. We also updated the study pool to support a change to the therapy.

Our team sent the high-quality materials to the FDA by the initial submission date. An FDA request for more information about the safety studies came late in the week and required a response by the following Monday. We recommended a new statistical analysis plan with additional clarity for the data summaries.

After receiving client approval, we worked through the weekend to format the data into a new table layout, complete programming and get the client’s final sign-off to submit the revised application by the Monday deadline.

Transformation

With our on-demand resources and clinical data management knowhow, the company received FDA approval for its innovative treatment. Most importantly, patients can now get the treatment they need and reduce the likelihood of the condition’s recurrence.

The pharmaceutical company can now submit applications more rapidly to numerous regulatory authorities with fewer queries and fast approvals thanks to the common, CDISC-compliant electronic format provided by Accenture. Accenture remains involved with the company’s future submissions.

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