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Newsletter 2019 October
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SDC Helps Feed Thousands on 3rd Annual Volunteer Day

September 18, 2019

SDC employees volunteered their time and talents at non-profit organizations across the country for our company-wide volunteer day on September 18, 2019. Our Arizona team joined a volunteer shift at Feed My Starving Children where we helped hand-pack nearly 58,000 nutritious meals for hungry and malnourished children in the Philippines. In Massachusetts, our team helped prepare and package meals at Community Servings, a not-for-profit food and nutrition program providing services throughout Massachusetts to individuals and families living with critical and chronic illnesses. Other team members volunteered at food banks, beach cleanups, and other non-profit organizations to strengthen their local communities.

SDC Volunteer Day 2019

SDC's Waltham (left) and Tempe (right) participants on SDC Volunteer Day 2019.

Philanthropy is an important part of our culture at SDC. Read more about the organizations we support at sdcclinical.com/about/philanthropy.

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Automating SDTM for Clinical Trial Data Submissions Using Artificial Intelligence and Machine Learning

Poster Presented on September 10, 2019

Melanie R. Ciotti, MBA, Marketing Strategist at SDC, presented a poster on "Automating SDTM for Clinical Trial Data Submission Using Artificial Intelligence and Machine Learning" last month at the AI Applications for Drug Discovery and Development conference, part of Biotech Week Boston. In the poster, she explains how an artificial intelligence model using machine learning and similarity methods can automate certain processes in converting raw data to SDTM-compliant formatting and the benefits of such automation. The full poster is available online at sdcclinical.com/innovation/publications-and-posters.

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Quality Assurance for Clinical Operations: Stress-Reducing Tips for a Successful Regulatory Inspection

Webinar Available on Demand

What is the difference between an inspection and an audit? What strategies can you use to avoid oversharing during gaps of silence with an inspector? How can you best prepare for a regulatory inspection? These are just a few questions the Quality Assurance experts at SDC and Stiris Research address in our webinar on "Quality Assurance for Clinical Operations: Stress-Reducing Tips for a Successful Reglatory Inspection." This webinar presentation is now available on demand at sdcclinical.com/QA-webinar.

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Employee Spotlight 

Kalyani Kothapalli, MS

Associate Director, Biostatistics

Kalyani Kothapalli Headshot - LinkedIn Photo

Kalyani Kothapalli joined SDC in 2015. As Associate Director, she serves as a consultant and senior reviewer for her team of clinical trial statisticians while also acting as the lead statistician for several studies. Prior to joining SDC, she worked at Quintiles (now IQVIA) and MDS Pharma Services in various statistical, programming, and managerial roles. She loves mentoring junior statisticians, improving processes, programming in SAS/R, and learning new statistical methodologies.

She has developed a wealth of knowledge over her 22-year career in drug and device clinical development, only some of which is described here. In oncology, Kalyani has supported clinical trials in multiple myeloma, advanced and metastatic solid tumors, non-small cell lung cancer (NSCLC), hepatocellular tumors, and melanoma. In ophthalmology, her experience includes presbyopia, glaucoma, x-linked retinoschisis, x-lined retinitis pigmentosa, achromatopsia, allergic conjunctivitis, and contact lenses. She has also supported clinical programs for asthma, endometriosis, migraines, amyotrophic lateral sclerosis (ALS), Meniere’s disease, idiopathic pulmonary fibrosis (IPF), diarrhea-predominant irritable bowel syndrome (IBS-D), and scoliosis and degenerative disc disease.

Kalyani holds a Master of Science in Biometry from the University of Nebraska in Lincoln, NE, and is a member of the American Statistical Association. Working from her home office near Kansas City, KS, she enjoys spending time with family, working out, reading, and watching TV.

Interested in joining our team? View our open careers and apply online today!

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Upcoming Events

We look forward to seeing you at one of the following events.

Conferences & Meetings

October 27-30, Las Vegas, NV
 
October 28-29, Boston, MA
 
November 12-13, New York, NY
 
November 19-21, Barcelona, Spain
 
January 13-15, San Francisco, CA
 
 
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