About Us

Who We Are & What We Do

Image

CTDD  Mission Statement

To create and support excellence and scientific integrity in clinical research that aims to benefit people with cancer.


CTDD  Vision

To independently or in partnership expand opportunities for clinical trial development, implementation, and reporting by cultivating a network of partners and building mutual loyalty.


CTDD  History

The CTDD started as the Buffalo Statistics and Data Management Center in the early 1970s as the National Cancer Institute funded Statistics and Data Management Center for the Gynecologic Oncology Group (GOG). The legacy GOG transitioned into the GOG Foundation, Inc. that includes both federally funded research through NRG Oncology and non-federally funded research through GOG Partners. The Clinical Trial Development Division (CTDD) of Roswell Park Comprehensive Cancer Center offers an experienced team that provides core clinical trial services. Our functional areas include, clinical trial management, biostatistics & statistical programming, data management, software systems development, IT infrastructure and quality assurance. We are part of the Department of Biostatistics and Bioinformatics Department and can leverage the expertise in other Divisions spanning statistical genetics and genomics and bioinformatics.

We Are Experts In Our Field

Image

Angela Kuras, BA, CCRP
Chief, Clinical Trial Development Division
24 Years Experience

Ms. Kuras is responsible for providing leadership, including oversight and supervision over all functions and projects of the Clinical Trial Development Division. She also directs the operations of the Roswell Park-based NRG Oncology Statistics and Data Management Center for both NCI’s National Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP). Ms. Kuras works closely with the biostatistics, administration, quality assurance and reporting, and information technology directors to ensure project goals are met and activities are completed in a timely fashion with optimal quality.

Image

Dr. Austin Miller, PhD
Director, Biostatics & Statistical Programming
16 Years Experience

Dr. Miller oversees all aspects of the biostatistical and statistical programming collaborations to ensure appropriate and efficient statistical methods are used in study design and analysis. He ensures work is done with a constant focus on trial integrity, feasibility, quality, accuracy and reproducibility. Additionally, he is part of the NRG Oncology Statistics and Data Management Center Biostatistical Unit.

Image

Sally Bially, MA
Director, Quality Assurance and Reporting
27 Years Experience

Ms. Bialy provides day-to-day oversight and management of the Clinical Trials Auditing and Monitoring Unit to ensure that all reviews are performed in accordance with Good Clinical Practice (GCP) and Clinical Trials Monitoring Branch (CTMB) guidelines. She works closely with audit and monitoring team staff to: 1. ensure highest quality and integrity of reviews; 2. identify systematic issues and propose solutions; 3. promote educational initiatives to perpetuate best practices observed by auditors and monitors. She continues utilizing her demonstrated track record of leveraging cutting-edge technology to support innovative strategies within the quality assurance and reporting domain.

Image

Meegan Becker, MA
Department Administrator
18 Years Experience

Mrs. Becker coordinates with department heads and central administration personnel to help ensure that sponsored research and related activities are in accordance with center policies and procedures. She assists department heads in administration and oversight of research and related activities. She assists department heads to assure that all key personnel involved in sponsored program administration have met training requirements in accordance with federal regulations and center and sponsoring agency policies and procedures. She works with department and center compliance and monitoring efforts related to sponsored program administration.

Image

Jonathan R. Kiddy, MS
Director, IT Operations
20 Years Experience

Mr. Kiddy plans, coordinates, and supervises operational activities for all information technology staff members in order to achieve departmental objectives. Mr. Kiddy provides direction and solutions that enhance mission-critical operations for the Clinical Trial Development Division. He manages all aspects of Information Technology including cloud computing infrastructure, software development, support services, and information security. Additionally, Mr. Kiddy is a member of the NRG Oncology Statistics and Data Management Center Information Technology Unit.

CTDD Services Summary


This office has provided full statistical and data management support for over 450 GOG trials and over 110,000 patient registrations. These trials include 119 Phase 3 clinical trials, 4 Phase 2/3 clinical trials, over 50 phase 1, and over 290 phase 2 trials, most of which were government funded.

Facilitated Patient Enrollment

Enrolled over 115,000 patients, 46,000 using full suite of software systems.

Captured over 2.4 million eCRFs

Customized data warehouse design, ETL process design and application integration.

Generated 350,000+ queries

Worked with a variety of international sites to rectify data issues. 2/3 were automated.

Tracked over 250,000+ specimens

Securely stored and managed the collection of a variety of biological specimens.

Facilitated over 17,000 electronic case reviews

Worked with sites across the world to ensure data integrity.

Several FDA indications

Paclitaxel, Bevacizumab, and Topotecan for Ovarian and/or Cervix cancer were based on GOG trials.