Clinical and Regulatory Writing.

Lotus Clinical Research medical writers are experienced in both clinical and regulatory writing techniques to provide concisely written documents. Our writers work closely with our biostatisticians and peer reviewers to ensure documents are complete and faithfully represent our high level of scientific rigor and patient care. Moreover, Lotus Clinical Research’s highly collaborative approach ensures well-formed documents that take into account client preferences, local regulations, and guidelines.

Lotus Medical Writing

As chairman of the APS and IASP clinical trial special interest groups, our chief scientific officer, Dr. Neil Singla, understands that certain protocol design elements predict success while others predict failure. He has published extensively in the field of analgesic methodology and placebo response mitigation. The knowledge he has garnered from these scientific pursuits allows Lotus Clinical Research to offer trial sponsors expert and customized analgesic medical writing services.

We have developed several templates of protocols, ICFs, patient diaries, and other deliverables for various pain models. These vetted analgesic templates allow us to prepare important documents with high quality and fast turnaround.

Some of the documents routinely prepared by our writers include:

  • Protocol synopsis documents
  • Clinical trial protocols
    Informed Consent Forms (ICFs)
  • Patient and staff diaries
  • Clinical study reports