Publications and Posters

Published Papers and Industry Posters

Automating SDTM for Clinical Trial Data Submissions Using Artificial Intelligence and Machine Learning
AI Applications in Drug Discovery and Development, September 2019
Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 TrialAm
American Journal of Ophthalmology, Published August 2019
Best Practices for ISS/ISE Dataset Development
PharmaSUG Conference, June 2019, Best Paper Winner in Applications Development
Automating SAS Program Table of Contents for Your FDA Submission Package
PharmaSUG Conference, June 2019, Best Paper Winner in Advanced Programming
Once-Daily Netarsudil vs Twice-Daily Timolol in Patients with Elevated Intraocular Pressure, the Randomized Phase 3 ROCKET-4 Study
American Journal of Ophthalmology, Published March 2019
Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution
American Journal of Ophthalmology, Published January 2019
Cone Photoreceptor Macular Function and Recovery after Photostress in Early Non-Exudative Age-Related Macular Degeneration
Clinical Ophthalmology, Published July 2018
Evaluation of Multiple Imputation Methods for Missing Diary Data for Statistical Analysis in Dry Eye Studies
ARVO Annual Meeting, April 2018
Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension
British Journal of Ophthalmology, Published July 2015
A Mixed Model, Repeated Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population
ARVO Annual Meeting, May 2015
The Clinical Data Management Process
Retina Today, November/December 2014
Power and Sample Size Calculations for Primary Open Angle Glaucoma / Ocular Hypertension Clinical Trials Accounting for Correlation of Measures among the Time Points across Visits
ARVO Annual Meeting, May 2014
Evaluation of Methods Handling Missing Diary Data for Statistical Analysis in Dry Eye Studies
ARVO Annual Meeting, May 2013
A Phase 2 Randomized, Double-Masked, Placebo-Controlled Study of a Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye
American Journal of Ophthalmology, Published June 2012
Statistical Methods for Non-Detectible Data in Tear Cytokine Measurements
ARVO Annual Meeting, May 2012
Evaluation and Selection of Statistical Analyses for Diary Data in Dry Eye Studies
ARVO Annual Meeting, May 2012
Ophthalmic Study Population Trends
ARVO Annual Meeting, May 2012
Sample Size and Power Tabulations in Dry Eye Clinical Trials
ARVO Annual Meeting, May 2012
Multi-Dimensional Testing to deal with Multiplicity in Clinical Trials
ARVO Annual Meeting, May 2012

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About SDC

SDC delivers top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. We are committed to providing experienced teams who will take ownership of your needs and are positively engaged in your projects. With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/IWRS) expertise at our core, our services are scalable via our diverse and complementary strategic partnerships to provide full service clinical trial solutions. Speak with us today to see why SDC is The Right Fit For You.

Publications and Posters

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

Netarsudil/Latanoprost Fixed-Dose Combination for Elevated Intraocular Pressure: Three-Month Data from a Randomized Phase 3 TrialAm

Best Practices for ISS/ISE Dataset Development

Automating SAS Program Table of Contents for Your FDA Submission Package

Once-Daily Netarsudil vs Twice-Daily Timolol in Patients with Elevated Intraocular Pressure, the Randomized Phase 3 ROCKET-4 Study

Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution

Cone Photoreceptor Macular Function and Recovery after Photostress in Early Non-Exudative Age-Related Macular Degeneration

Evaluation of Multiple Imputation Methods for Missing Diary Data for Statistical Analysis in Dry Eye Studies

Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension

A Mixed Model, Repeated Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population

The Clinical Data Management Process

Power and Sample Size Calculations for Primary Open Angle Glaucoma / Ocular Hypertension Clinical Trials Accounting for Correlation of Measures among the Time Points across Visits

Evaluation of Methods Handling Missing Diary Data for Statistical Analysis in Dry Eye Studies

A Phase 2 Randomized, Double-Masked, Placebo-Controlled Study of a Novel Integrin Antagonist (SAR 1118) for the Treatment of Dry Eye

Statistical Methods for Non-Detectible Data in Tear Cytokine Measurements

Evaluation and Selection of Statistical Analyses for Diary Data in Dry Eye Studies

Ophthalmic Study Population Trends

Sample Size and Power Tabulations in Dry Eye Clinical Trials

Multi-Dimensional Testing to deal with Multiplicity in Clinical Trials

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