Welcome

I am a compassionate and dedicated clinical data consultant, providing top-tier data management services and innovative solutions to advance clinical research. Let’s discuss how my expertise can support you and your teams, drive meaningful results, and make a lasting impact in the world of clinical research!

About Me

With over 20 years of experience in preclinical and clinical research, I bring a deep passion and skillset to Clinical Data Management. My journey has given me a broad understanding of various data management systems and therapeutic areas, allowing me to lead data management activities with exceptional precision and dedication.

Throughout my career, I've always prioritized quality, accuracy, and timeliness in my work. I'm committed to handling every project with the utmost care and attention to detail, using my education and experience to support project success. I strive to drive excellence, foster innovation, and deliver meaningful results that positively impact the field and those it serves.

Indication Experience: Advanced or Metastatic Solid Tumors, Relapsed and/or Refractory Multiple Myeloma, Recurrent High-Grade Glioma, Diabetic Foot Ulcers, Mountain Cedar pollen allergic sensitivity, Non-Small Cell Lung Cancer, Ocular Inflammation and Pain Following Cataract Surgery, Migraine, Basal Cell Nevus Syndrome, Molluscum Contagiosum, Relapsed or Refractory Acute Myeloid Leukemia, Retinitis Pigmentosa, Study Drug Bioavailability in healthy subjects.

Services

I provide comprehensive data management solutions tailored to meet the needs of clinical research projects. With extensive experience in overseeing CROs and collaborating with sponsors, I ensure that all data management activities are conducted with the highest standards of quality and efficiency. I lead dedicated data management teams, ensuring seamless coordination and reporting to company leadership.

Key Services:

  • Data Management Oversight of CRO and accompanying vendors

  • Partner and collaborate with sponsors for data management activities

  • Lead data management teams and report to company leadership

  • Develop and implement data management strategies and SOPs

  • Ensure data quality, accuracy, and compliance with regulatory standards

Database Experience:

  • Medidata RAVE®

  • DATATRAK™

  • Medrio

  • TrialKit (formerly ClinStudio)

  • IBM Merge

  • Veeva Vault CDMS

  • DataFax® and iDataFax®

  • SynCapture™ (Synteract’s proprietary EDC platform)

References

  • “I highly recommend Silva for her exceptional critical thinking, organization, attention to detail, and collaborative approach. As our data manager on a project with demanding timelines, Silva planned and executed tasks with high quality and punctuality, ensuring project success. She proved to be a thoughtful partner, adeptly analyzing complex situations and swiftly adapting to our evolving needs. It is my pleasure to count Silva as our preferred partner for data management.”

  • “Silva is an exceptional leader and colleague. Her expertise and collaborative approach have been invaluable in steering complex projects toward success. Silva is skilled in managing tight deadlines while maintaining high-quality standards. She is a reliable and insightful partner, eager to find and commuicate solutions with her team.”

“Alone we can do so little; together we can do so much.” - Hellen Keller