The pharmaceutical industry is undergoing a huge transformation. The traditional ways of clinical research will soon be a thing of the past, with disruptive technologies like machine learning (ML), artificial intelligence (AI), natural language processing (NLP) and robotic process automation (RPA) moving from niche positions to sweep across the pre-clinical and clinical research value chains
With new FDA requirements that took effect in December, 2016, you must be able to receive and submit non-clinical toxicology study data in the SEND format. The new SEND standards have a major impact on the industry, as they are now binding for all sponsors submitting non-clinical data to the FDA — re-structuring the way non-clinical data is collected and submitted.
Long-running legacy processes and a lack of standards have led to inconsistent data standards that differ from company to company. Moreover, there may be inconsistency at many levels within a single organization, depending on the enforcement of these standards.
- Sponsors whose studies started after Dec. 17, 2016, must submit data in the data formats supported by FDA and listed in the FDA Data Standards (CDISC –SEND) Catalog. This applies to NDAs, BLAs, ANDAs, and subsequent submissions to these types of applications.
- For INDs, the requirement starts after Dec. 17, 2017.
The major challenges that the industry is facing with SEND implementation are:
Lack of resources with deep SEND and study-specific expertise
- Deep standards knowledge is required for trial design creation and Study Data Reviewer’s Guide (SDRG) content analysis and authoring
Tools for viewing study data and cross-study analytics
- Increasing need for data exploration
- Deployment, integration, advanced visualization and support for the selected system(s)
Global harmonization of SEND processes after mergers & acquisitions
Time-consuming and costly manual data QA checks
- Existing products do not provide certain automated data checks
- Many companies are using older Laboratory Information Management Systems (LIMS), which do not support SEND-compliant data collection
Data merging issues
- Use of multiple LIMS systems
- Multiple source files from CROs, in-house labs, etc.
Implementing SEND standards requires deep knowledge and expertise in understanding, planning, implementing and submitting non-clinical data to regulatory bodies. Small errors complying with SEND standards may result in a rejection, making it imperative that your submissions are prepared by experienced and knowledgeable subject matter experts.
We are here to listen. At Syntel, we understand the core problem, and put our experience to work addressing this challenge with a two pronged approach.
- Ready pool of SEND SMEs. Implementing SEND standards is a niche skill, and it can be difficult to identify and hire the right team members. Syntel has a comprehensive process to find the right talent for your organization, including a n extensive screening process, SEND-specific training, an ongoing competency building approach, and a robust knowledge management framework.
- Quality assurance (QA): QA demands 100% adherence to SEND standards and processes, along with data consistency. We ensure that your SEND data is consistent with the original LIMS data resource, and conforms to the FDA’s implementation of the CDISC standard.
Syntel offers a full range of SEND operational and data management services, with a pool of trained, talented team members ready to deliver high-quality service based on SEND and QA processes, established information security controls, and a scalable model ready to help you build a world-class SEND organization.
If you are ready to put your SEND compliance initiatives on the right track, you need to talk to one of our experts today and learn how Syntel can deliver the mix of skills and quality that you’ve been looking for.
Contact us at Syntel_lifesciences@syntelinc.com today.
Gauri Deshmukh is a Senior Consultant – Life Sciences at Syntel, providing Domain Solutions to...