Medical Writing

To provide medical writing of the highest quality, our projects are headed by an experienced research person who is focused on tracking a clinical project from its inception to the final study report. Our in-house medical writers are involved in important project communications through every stage to ensure a comprehensive understanding of the study. The final study report is documented along with the inputs of the statistical department.

Delivery of your final, summarised data will be presented in paper copy as well as password-protected electronic files. We observe all formats and SOPs specified by the sponsor and all documents are proofread by a native speaker.

The Medical Writer is Closely Involved with the Following:

Study Protocol

This includes biometric study planning and sample size calculation. All protocols are written according to ICH GCP, national laws and indication specific guidelines.

Case Record Form

CRFs have been delivered to all continents - reliably, on time and precise in wording, mono-, bi-, or multilingual and designed for a complete data recording according to ICH GCP guidelines. In addition, Oracle-based electronic CRF is available in CRF layout for studies which run with paper CRFs and RDE in parallel.

Reporting

At Navitas, clients are provided with in-depth and clear medical reports and integrated reports according to ICH- GCP guidelines.

In addition to the above, our medical writing team also provides support with:

  • Safety summaries and narrative writing
  • Manuscript preparation for publications
  • Investigators’ brochures
  • Expert reports
  • Data review for special therapeutic areas by clinicians

Patient Diaries

The advantage of electronic patient diaries has resulted in the decreased use of paper diaries due to their unreliability with errors and speed of data collected. As an option, Navitas Life Sciences offers our customers the possibility to use Electronic Patient Reported Outcomes Diary solutions (ePRO) which will improve data quality and patient compliance and shorten the time of clinical trials.

The ePRO solutions available include:

  • IVR solutions -Interactive Voice Response System solution
  • PALM-based solutions
  • Wireless audio data transmission
  • Web-based solutions (data immediately accessible via a secure web site)

Functional Outsourcing

We provide a team of medical and scientific writers, SAS programmers, medical coders and related professionals dedicated to a sponsor who want high-quality service customized and delivered in a secure environment from India where such talent with domain knowledge is available at competitive cost.

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