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Clinical Research Services
CDISC and Regulatory Services Clinical Data Management Biostatistics and SAS Programming Pharmacovigilance Medical Writing Clinical Operations  
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LAXAI has a team of highly skilled and qualified medical writers who ensure scientific relevance, accuracy and consistency. Our medical writers have experience in multiple therapeutic areas and ensure that the documents comply with ICH guidelines and regulatory requirements. We offer the following Medical Writing services
  • Protocol preparation
  • Designing Case Report forms
  • IND/NDA/ANDA preparation
  • Statistical Report Preparation
  • Protocol Authoring Services
  • Investigator's Handbook preparation
  • Informed Consent preparation
  • Standard Operating Procedures preparation
  • Subject Recruitment documents
  • Submission Docket preparation (local and global)
  • Clinical Study Report (CSR) preparation
  • Package Inserts Preparation
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