Complexity of protocols have increased over the last few years due to the adaptive and distributed nature of clinical trials – and this demands state-of-the-art clinical data management systems and services to simplify study design, conduct, discrepancy management and compliance.

Why Clinical Data Management Services?

Collecting, storing, and curating large amounts of scientific data is important for regulatory compliance. Greater aggregation of data, and its reuse, not only reduces the cost of clinical research significantly, but also accelerates the drug development process.

Specialized clinical data management services can enable the following:

  • Ensuring quality and integrity of clinical data
  • Compliance to global standards to ensure consistency of clinical data management
  • Adoption of specific technologies and best practices in data management

How Can Navitas Help?

Navitas is a Leader for our clients in the life sciences industry, providing services that make clinical research data management processes more efficient and predictable. We understand the intricacies of clinical data management. We have demonstrable capabilities and extensive experience in helping global life sciences organizations with clinical data management processes. Navitas can handle paper-based and electronic data capture (EDC) trial studies across different therapeutic areas and managing data throughout the study life cycle (from study design, conduct, discrepancy management and compliance) as per the regulatory standards.

Navitas recognizes the importance of clinical data management in the drug development process. We offer remote clinical trial data management services in an FDA / EMA compliant secure environment.

Navitas brings you the combined advantage of experienced, professional data management personnel with expertise in medical device, biotechnology, and pharmaceutical therapeutic areas. Demonstrated flexibility to using paper- or EDC-based systems, demonstrated flexibility to using either our internal EDC system or one of your choice. Navitas also provides well-documented and well-maintained Data Management Plans thorough user acceptance testing (UAT) for EDC studies and ensures thorough testing of paper-based databases carried out by strong, motivated project teams

Offerings

  • Development of paper CRF/eCRF Paper CRF printing and distribution
  • Paper CRF tracking
  • Double-key data entry (paper CRF)
  • Clinical database design and set-up
  • Deliverable clinical database developed using CDISC SDTM standard
  • Data definitions provided in accordance with CDISC CRT-DD specification
  • UAT in EDC systems Management of electronically transferred data (Central labs, central readers, etc.)
  • EDT specification
  • Reconciliation of transferred data against CRF data
  • Integration of transferred data into clinical database
  • Data validation
  • Query generation & resolution
  • Review of resolved queries in EDC systems
  • SAE reconciliation
  • Coding of medical terminology (adverse events, medical history, medications)
  • MedDRA
  • WHO Drug Dictionary
  • Clinical database lock
  • Clinical database transfers (interim, final)
  • SAS datasets
  • SAS XPORT transport files

Maintenance of Web-accessed study-specific tracking systems (enrolment, CRF/query tracking)

clinical database

  • All
  • AMS
  • BI
  • Brochure
  • CaseStudy
  • Clinical
  • CMS
  • MedicalDevices
  • On DemandWebinar
  • Quality
  • Regulatory
  • Safety
  • Technology
  • Whitepaper

Latest News

20
Apr2017

ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and...

Navitas welcomes the opportunity to provide comments on this Reflection Paper... Navitas welcomes the opportunity...

13
Apr2017

Navitas Life Sciences Augments Global Executive Management Team

Navitas Life Sciences announced the appointment of Dr. Krishnan Rajagopalan as Chief Growth Officer....

24
Jan2017

Navitas Networks announce Forum dates for Spring, 2017

The Navitas Networks are pleased to confirm the dates for our upcoming Spring forums... ...

17
Jan2017

Navitas Launches Labeling Assessment Express

Regulators are changing the way they look at labeling. The emphasis is on ensuring...

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present "Efficient content management for the compilation and...

04
Oct2016

News 2016

[row id="1" class="ROW_CLASS"] [col class="span12"] 02 Nov 2016 AbbVie and Navitas Present Case Study on the Evolution...

27
Sep2016

Navitas releases paper on CDISC, the standards and why the...

The FDA (and eventually, regulatory agencies from around the world) will require clinical data...

13
Sep2016

AbbVie and Navitas Present Case Study on the Evolution and...

At 10:30a.m. (East Coast Time) on September 22nd, Navitas and AbbVie will...

29
Jul2016

Navitas Networks announce Forum dates for Autumn, 2016

The Navitas Networks are pleased to confirm the dates for our upcoming Autumn forums....

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite...

28
Jun2016

Navitas' PVTech Summit Defines Future Success

Navitas’ PVTech Summit was held on June 15th at the Hudson Hotel in New...

18
May2016

Navitas Welcomes Tara Baer to Navitas

Navitas is pleased to welcome Tara Baer, who joins Navitas' Regulatory Practice. With over...

18
May2016

Navitas Speaks at Sparta Connection in Orlando

David Gwyn, Navitas' Technology Practice lead, will unveil idmpREADY at the Sparta Connection conference...

14
Mar2016

Navitas Earns Speaking Sessions at DIA’s 52nd Annual Meeting

In two different sessions, Subject Matter Experts from Navitas will address new challenges facing...

09
Mar2016

Navitas is pleased to announce the introduction of our networks...

Navitas' inaugural pvindia meeting took place in Mumbai on Thursday 03 March, 2016. ...

25
Jan2016

Navitas Announces the Inaugural pvindia Forum

Navitas will soon be adding to our portfolio of industry leading networks with the...

18
Jan2016

Navitas Relaunches pharmaREADY.com

pharmaREADY.com is Navitas' next generation website for its fully integrated, regulatory compliant document management,...

14
Dec2015

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and...

Steve Arlington, Navitas Advisor, Spoke on the Challenges, Opportunities and Future of the Pharmaceutical...

03
Nov2015

The changing trends in drivers of life sciences R D...

Outsourcing is not new in the life sciences sector. Clinical research outsourcing, contract sales...