Company: 

EVERSANA

EVERSANA

One of the most remarkable aspects of Niche Science & Technology Ltd. is their commitment to staying at the forefront of advancements in science and technology. The team is known for its professionalism and reliability. They exhibit exceptional communication skills, ensuring that projects progress smoothly and efficiently. Many EVERSANA colleagues have worked with the NST team in the following areas and have always reported outstanding results:

  • Editorial and medical writing support – including regulatory documents, scientific manuscripts and conference publications
  • Strategic input on regulatory and medical affairs
  • Compilation and writing of the non-clinical IMPD, Investigator’s Brochure and the clinical protocol for our studies
  • Assembling and filing the Clinical Trial Applications and ethics submissions
  • Acting as legal representative in the UK
  • Monitoring the clinical trials on a regular basis to ensure protocol compliance
  • Serving as a source of ‘on demand’ regulatory advice and guidance
  • Communicating with competent authorities for submissions, guidance and reporting
What our client said

"Having had the privilege of interacting with Niche Science & Technology Ltd. on various projects, I can attest to their unparalleled dedication to excellence, innovation, and integrity."

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Dr Mike Ryan, EVP

EVERSANA




Project background
EVERSANA is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organisations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world.
Delivery

NST began work with EVERSANA in 2022, providing support guiding a late-stage development biotech company with an asset for Alzheimer’s disease. The company had expended considerable resources on delivery of their Phase II/III clinical programme. Their latest Phase III trial had followed a 15-month study in mild to moderate patients that showed no treatment benefits. Their latest trial was also apparently negative, possibly as a result of poor study design, and the company was trying to make sense of their data. The NST team devised regulatory strategy around interpretation of the opinion offered by the FDA and MHRA and future study designs. They also provided advice on the use of publicly available registry data to compare against their own data.

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