It is World Statistics Day on 20th October, and we would like to highlight how effective biometric support is rising as a top strategic priority for running efficient clinical trials. Data services have been shown to ensure tremendous clinical trial value, as the analysis and insights provided aid in the wiser management of clinical trials.
Navitas Data Sciences Adheres to Regulations in Clinical Data Management
Certain guidelines need to be followed for clinical data management in clinical trials. Electronic records that are created, maintained, modified, or even transmitted should comply with a Code of Federal Regulations (CFR), 21 CFR Part 11. Another important document that includes good standards for clinical data management is the Good Clinical Data Management Practices (GCDMP) published by the Society for Clinical Data Management (SCDM).
There are standards that need to be maintained for the exchange, acquisition, submission, exchange, and archival of clinical research data, which has been developed by the non-profit organization, Clinical Data Interchange Standards Consortium (CDISC). There are several important Foundational Data Standards that are provided by CDISC.
- The Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data in a similar manner across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into SDTM.
- The Study Data Tabulation Model (SDTM) provides a standard for organizing and formatting data to streamline processes in the collection, management, analysis, and reporting of the raw data.
- The Analysis Data Model (ADaM) defines dataset and metadata standards that support the generation of analysis datasets. This includes efficient generation, replication, and review of clinical trial statistical analyses; and traceability between analysis results, analysis data, and data represented in SDTM.
Navitas Data Sciences has biometric FSP outsourcing solutions that can help sponsor’s clinical data adhere to the necessary guidelines for regulatory approval.
Navitas Data Services is your Preferred Global Functional Service Provider (FSP)
Navitas Data Sciences builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers, ensuring accuracy and precision in the work delivered.
Expert-Driven Biometric Support Since 1993
Our expert-driven Statistical Programming, Biostatistics, and Data Management services support you in reaching successful clinical trial outcomes. Our Biometrics expertise supports all clinical trial phases throughout the drug development life cycle. Our blended team of highly skilled experts provides complete data support or augments your existing team.
Dependable Functional Service Provider for your Biometric Needs
Mike Cox, Client Partner - Business Development, Navitas Data Sciences (a part of Navitas Life Sciences) provided insights about our flexible data services model. Here is an excerpt of the interview.
Explain in brief about Navitas Data Sciences
For almost three decades, first as DataCeutics, and now as Navitas Data Sciences (NDS); we’ve been proud to build teams of experts needed to support drug development. NDS will be celebrating 28 years this November and in that time, we have assisted in over 150 drug submissions while growing to over 140 industry veterans.
Client Partner - Business Development
Navitas Data Sciences
(a part of Navitas Life Sciences)
What is the FSP model and how is it advantageous?
NDS offers a range of bespoke FSP models assembled to fit varying sponsor needs or budgets. Here are the advantages of an FSP model:
- Sponsors save on recruiting fees
- Lower human resources management fees
- Sponsors save on training cost
- Improved services provider relationships
- Increased resource flexibility
- Provides access to a specific skill/expertise
What are the advantages of working with Navitas Data Sciences?
The advantage of sponsors working with NDS for their FSP needs is primarily the presence of dedicated and sponsor-specific teams, regardless of geography, only working on sponsor’s programs leveraging their processes, SOPs, and systems.
Also, every FSP engagement is given a seasoned Project Manager (PM). All of our PMs are functional and technical. They are expected to roll up their sleeves and code as well as provide the critical thinking necessary to allow the sponsor’s preference of involvement.
Another key advantage is the 3-tier Governance Structure that works to enable strong communication and immediately address any issues, with direct access to NDS Executive Leadership.
What is the latest trend in the Clinical Trial Industry?
Mergers and acquisitions of large Clinical Research Organizations (CROs) has been a theme in 2021. In addition, more work than ever is being outsourced to these large CROs and if this continues, we imagine small to medium sponsors’ deadlines may be at risk from their CRO’s increased competing priorities. Adding a biometric FSP to your outsourcing strategy can help mitigate this risk and allow these small/medium sponsors to pivot at critical times of need.
Navitas Data Sciences is a Virtual Diamond Sponsor at the CDISC 2021 US Interchange
Schedule a meeting with our team of experts and learn how we can help you to meet the future challenges of data requirements in your clinical trials