In the FDA’s Position Statement released on September 13, 2013 the importance of standardized study data and its positive impact on a “reviewer’s ability to more fully understand and characterize the efficacy and safety of a medical product” was made very clear. The FDA also stated that it will be producing more guidance on the use of CDISC and will require study data in conformance to CDISC standards.
Why CDISC Standards?
CDISC is here to stay and the need for having a sustainable data standards strategy and execution plan is critical in today’s regulatory environment. Compliance is only a small component of the value of standardized clinical and medical data. There is significant business value that can be derived from an effective clinical data standards approach. In fact, we believe it will play a critical role in establishing a company as a leader in your targeted therapeutic areas by enabling mechanisms to gather and assess true clinical benefits and cost effectiveness in real-world settings. The ability of market leaders to leverage clinical data in three ways is proven to establish top brands. The three areas to focus on are:
- Ensure superior evidence to make the case for clinical differentiation and value-based reimbursement and leverage investment in producing long-range efficacy studies that demonstrate broader health system savings through improved quality of life
- Utilize “lifecycle” planning to drive top value for a drug
- Take every opportunity to translate health economics, clinical benefit, and safety issues into simple messaging focused on the quality of life of the patient
How Can Navitas Help?
Navitas has been helping clients drive business value from their clinical data standardization for many years. We are experts in understanding clinical data flow from protocol to patient. Navitas has a team of senior CDISC consultants to ensure there is an accurate interpretation of the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) that is identified, documented, managed, implemented consistently, and most importantly, communicated to the Sponsor. Navitas has been contributing significantly to the CDISC SDS (Submission Data Standards) team for several years and is a global registered solutions partner.
Navitas operates a Clinical Data Conversion Factory with a combination of onshore and offshore resources that provides extensive CDISC expertize. We are well positioned to handle high volumes of CDISC SDTM & ADaM conversion projects by utilizing highly skilled and trained teams in the US and India. This delivery model provides highly cost-effective and quality standardization services. Our approach to cost effectiveness with quality is achieved by having thought leadership, quality control and quality assurance in our US offices with the majority of conversion execution activities being performed in India. Navitas has a reputation for delivering quality solutions on-time and within budget for many leading Biotechnology and Pharmaceutical companies both local to the U.S. market and worldwide.
- Conversion to STDM
- Conversion to ADaM
- Define.XML Creation
- Reviewers Guide Creation
Navitas also provides an array of Technology Services and Business Process outsourcing solutions in the areas of Clinical Data Standardization, Biostatistics, SAS Programming, Global Regulatory Submissions and Drug Safety to major Life Sciences companies.