Clinical Development Consultants

Danik Innovations LLC offers a unique blend of clinical strategy development and implementation expertise for our clients in the pharmaceutical industry.

We assist our clients in designing, implementing and reporting of global clinical development programs in various therapy areas including: vaccines, immunology, infectious diseases, cardiovascular, and respiratory. We offer clients the benefit of our extensive expertise in clinical trial planning, data review, interpretation, medical writing, submissions, and review of clinical documents from Phase 2 through Phase 4 of clinical development

Business Development & Clinical Strategy

Generate Executable Clinical Development Plans
Review and Interpretation of Clinical Data
Critical Review of Clinical Plans for Fast-Track and Breakthrough Designation Status
Support Comprehensive Due Diligence Activities

Medical Writing

Write & Review Clinical Documents from Pre-Study to NDA, BLA & MAA Submissions in Multiple Therapy Areas

Protocols & Amendments
Study Reference Manuals
Informed Consents & Assents
Investigator Meeting Materials
Clinical Study Reports
Safety Updates & Narratives
Clinical Section of Pre-IND and IND Documents
Overviews & Summaries of Efficacy & Safety
Manuscripts for Publications

Clinical Development Consultants

Business Development & Clinical Strategy

Medical Writing

Downloadable documents