|Quality & Auditing|
|Life Science Experts|
Designed for very young companies with a small number of employees and limited applications who are likely in the discovery phase.
For companies still in early clinical trials (likely Phase I or II) but requiring a larger database and 21CFR11 compliant document management.
For companies with candidates progressing successfully into Phase II or III trials and preparing for FDA submission and commercialization.
Young biotech and pharma just starting out are focused on one thing, science. The company has a limited number of employees with basic needs in email, website and document management.
The important thing is, successful, young Life Science companies won't have limited IT needs for long. They will file their Investigative New Drug application and start development and clinical trials leading to FDA approval. Progressing through this process comes with more regulations and more sophisticated requirements in their IT infrastructure and document management.
The first and most significant question is, what do companies need in their information systems that is good enough for today but that will prepare them for tomorrow's regulatory needs?
Court Square Group has developed three solutions for that very question. GSPBio is a line of managed services offering hosting and management of infrastructure, applications and special life sciences applications in three main stages of the emerging biotech company's life cycle.