CDISC Services


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CDISC Services

Driving business value with our proven clinical data standardization approach                                                                        

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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. But compliance is only a small component of the value of standardized clinical and medical data. There is significant business value that can be driven 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 TAKE Life Sciences help?

TAKE Life Sciences 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. We have developed a Clinical Data Conversion Factory with a combination of onshore and offshore resources that provides:

  • CDISC STANDARDS EXPERTISE: TAKE Life Sciences 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. TAKE has been contributing significantly to CDISC SDS (Submission Data Standards) team for several years.
  • SCALABILITY and GLOBAL DELIVERY MODEL: TAKE is well positioned to handle high volumes of CDISC SDTM conversion projects by utilizing highly skilled and trained teams in the US and India and this delivery model provides highly cost-effective and quality standardization services. We are equipped to handle all of the conversions in an out-sourced model and executed from our global (U.S and India) offices. 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. This model has been working well with ongoing conversions.
TAKE-Engagement-model
  • SECURITY: TAKE 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. More than 40% of TAKE’s global revenues come from servicing Fortune 100 and Mid-sized Biotechnology companies. TAKE is providing 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.

For more information about our CDISC Capabilities and how we can help you to drive business value, please email us at This email address is being protected from spambots. You need JavaScript enabled to view it.

Contact Us

For LS sales call (Princeton, US) +1 877 320 3626 X 230
For SCM sales call (Austin, US) +1 800 324 5143

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