Clinical and Regulatory
The drug development pipeline is the life blood of a company. A quality, rigorous, documented process from development to submission is the single most important item to increase revenue for life sciences companies. The quantity of data being collected throughout this process can be overwhelming for even the most mature companies. The data collected through clinical trials is an important piece of intellectual property. It also directs and drives the process toward the goal of submission and commercialization. This causes excessive pressure during the regulatory submission due to the lack of organized information resulting in unnecessary delays in submission. A company that has an information strategy and related complementary systems will significantly improve the timing and quality of their submissions
Court Square Group’s subject matter experts and products can support a company’s clinical and regulatory needs from assessment to business process improvement to fully implemented and validated application systems. Specific services are offered in the areas of electronic Common Technical document (eCTD, Electronic Data Capture (EDC) and esubmissions.
Strategic Information Consulting
Court Square Group provides expertise to organize your information in a logical way to ensure that all clinical and regulatory information is captured and integrated. Our expertise in business processes and regulations with an emphasis in critical systems such as (EDC), Clinical Trials Management Systems (CTMS), safety and adjudication systems, and (eCTD) submissions provides the client with the right investment in the right technology that best leverages your companies’ business and submission strategy.
Project Selection & Implementation
Court Square Group project management office provides disciplined project management to take you through selection and implementation of applications that best suit your needs. With your requirements, we can select the best technology that suites your business, information, and regulatory needs while staying within your budget. Court Square can provide support for all of the process or elements where you need assistance. The result will be clearly defined requirements with a vendor selected and audited, a project plan created and implemented and final reports detailing the implementation plan and the validation reports necessary for auditing.
Hosting and Support
Court Square Group provides complete hosting for your clinical and regulatory information and applications. This is ideal for companies that want to focus on bringing their products to market while avoiding a major investment in technology. Our strategic channel partners in the areas of EDC and eCTD (link to partners page) give us more leverage for your particular needs. For more on our hosting solutions, please click here.
