The Clinical Trial Design and Specifications:

We are excited to share a remarkable success story highlighting our team’s dedication and expertise at NoyMed CRO. This time, we became a vendor for a groundbreaking phase 1 clinical trial conducted in the therapeutic area of infections. This trial stands out among other studies in the same therapeutic area, as it distinguishes itself by its intricate nature and vast reservoir of data.

The trial consisted of two key stages: the Single Ascending Dose (SAD) phase, involving approximately 100 patients, and the Multiple Ascending Dose (MAD) phase, with around 80 participants. It was a double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of the investigational treatment. 

Precise Data and Analysis as the Base of NoyMed’s Success:

An accomplishment of this clinical study was the swift and efficient data analysis and review. We were entrusted with the mission of delivering biostatistics, full data management, SAS Programming, and CDISC conversion solutions. 

Thanks to the efforts of our SAS programmers, our team was able to complete the crucial tasks of data analysis and review within an impressive 2 weeks after the database lock, saving 4 weeks compared to the average industry time due to several key factors:

• The first factor behind NoyMed’s success in this particular trial was the exceptional professionalism of our statistical analysis team lead, whose resource planning, commitment, and effective workflow design are advantages worth mentioning. 
• Another contribution was the mastery of NoyMed’s SAS programmers. Our SAS programmers deliver the finest-quality results adhering to tight timelines by optimizing Log Check and Comparison study-specific macros developed within years of experience in various therapeutic areas of clinical research.

The Outstanding Flexibility and Task Management of NoyMed’s Data Managers:

Regardless of the extra workload, the data management team embraced the challenge and went above and beyond to deliver value. They allocated robust data management practices to accommodate the expanded scope. The team leveraged their data review and management expertise to extensively contribute to the study’s conduction.

Moreover, the data management team demonstrated flexibility in terms of timelines. Sensing the urgency, the Data management team adjusted their schedules and worked collaboratively to develop alternative solutions, ensuring the project stayed on track. They demonstrated decision-making skills in multiple critical situations, earning the approval and agreement of the client. Their decisions resolved the challenges and introduced innovative solutions that brought about positive outcomes for the study.

Summary:

We extend our gratitude to the entire team involved in this clinical study, whose collective efforts and unwavering commitment made this success story possible. We are honored to have played a significant role in advancing the field of infections, coming up with novel and solid SAS programming optimizations, and contributing to the development of potentially life-changing therapies.

NoyMed’s accomplishments in clinical trials of various therapeutic areas, from oncology to ophthalmology and neurology, serve as a testament to the 10+ years of expertise in more than 170 clinical trials and stand behind an unmatched 95% retention rate from partners and sponsors!