FDA News

Court Square Launches Clinical and Regulatory Practice

(June 010, 2008)-- Court Square Group, a professional services firm specializing in strategic information technology, business process and project management consulting, announced that it has launched a Clinical and Regulatory Practice within its Life Sciences Business Unit.

“Our comprehensive suite of life sciences services addresses the needs of biotech and pharmaceutical firms throughout the drug development lifecycle,” said Court Square CEO Keith Parent. “The Clinical and Regulatory Practice enables our clients to employ on-demand electronic data capture during clinical trials and couple that data with electronic submissions of required regulatory reporting. Today, we provide both capabilities as on-demand or software-as-a-service (SaaS) applications, allowing clients to quickly employ advanced technology without incurring heavy capital expenditures.”

“I’m also happy to announce that we have named Andy Sontag Vice President of the Clinical and Regulatory Practice,” said Parent. “Andy has 20 years of IT and business experience at leading life sciences firms. His ability to combine IT and business improvements will be invaluable to our clients.”

At AstraZeneca, Sontag, who holds an MBA from Nichols College, implemented business process and IT improvements in drug development, quality assurance, supply chain management, financial systems and manufacturing controls. During his tenure at Boston Scientific, Sontag managed the firm’s entire technology suite, from preclinical to regulatory, along with the finance and quality functions. He streamlined drug development by adopting IT systems for electronic data capture, safety and adjudication, clinical trial management, and more.

“I’m excited to join Court Square and look forward to helping our clients benefit from time-and-cost saving technologies and business process improvements,” said Sontag.

“Court Square makes it possible for small and mid-sized companies to adopt the FDA’s guidance and industry trends regarding their regulatory submissions. The use of electronic common technical document (eCTD) specifications for investigational new drug applications (INDs), new drug applications (NDAs) and other related regulatory documentation can expedite the approval processes for all companies with our products and services.”

“The FDA is encouraging drug makers to go electronic, and the industry is responding, thanks to the financial savings and time-to-market benefits involved,” said Sontag. “We start by auditing the client’s business processes, information flows, applications and IT infrastructure, then provide best practices options. Ultimately, most decide to drop their paper-based, error-prone approach in favor of using on-demand solutions that dramatically cut costs and improve their data integrity.”

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