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Medical Writing

We understand the importance of effective medical writing to the successful development of a product. We provide medical writing experts in the following areas, including: 

  • Clinical study reports

  • Study protocols, amendments, and administrative changes

  • Patient narratives

  • Investigator brochures

  • Aggregate reports (ASRs, PSURs, IND update reports)

  • Regulatory agency submissions

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CTMS Develepment

We are partnered with CTMS development company and help our clients to optimize the entire study process efficiently and seamlessly. The CTMS will help our clients in the following areas:

  • Electronic Data Capture System (EDC)

  • Data Management

  • Randomization

  • Safety Reporting

  • Material Tracking

  • Site Monitoring

  • Regulatory Management

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Communications

Because your satisfaction is our top priority, we will provide you with a single point of contact throughout a project whose job is to communicate on a timely basis and make sure your requirements are being met throughout the life of the project. We expect that, during a project, there will be a very close relationship between our teams, particularly between our biostatisticians and the client’s functional groups (e.g. project management, data management, programming or medical writing).  Our management will also be checking with the client and with the point of contact during the project to ensure that the relationship is working successfully.