Life Sciences

Life Sciences companies—document and information-intensive businesses—operate under continual scrutiny from both domestic and international regulatory authorities.

Sitrof Proven.

Sitrof brings dozens of years of experience implementing content management, document management and business process automation solutions for clients in life sciences. Whether the need is to better collaborate with external organizations or to harmonize processes after a merger or acquisition, Sitrof has been there, done that.

Because the FDA won't go away.

Mounting business pressures in pharmaceutical, biotechnology, medical device, health care, clinical services and other related industries that requires companies to wring ever greater returns from their operations. In this unforgiving environment it is vital that organizations maintain compliance with governmental regulations such as the FDA, the US Health Insurance Portability and Accountability Act (HIPAA), and other industry standards—efficiently and effectively.

Whether it is maintaining 21 CFR Part 11 compliance on your computer systems or having the proper procedures in place for DDMAC submissions, Sitrof has the right combination of people, processes and technology to solve your business problems.  Sitrof. Proven Results.

Compliance

Because the FDA isn't going away. Sitrof provides intelligent unstructured data management and document management services to life sciences to gain compliance and mitigate risk. Backed by decades of industry knowledge and world-class industry partnerships, S ... READ MORE

Safety

Adverse event (AE) reporting has always been a labor intensive but critically important operation. AE source documents arrive via mail, fax, email—even from call centers as a voice record. Unlocking the source documents from paper files becomes an imperativ ... READ MORE

Regulatory

Authoring. Collaboration. Electronic signatures. Process harmonization. Part 11 compliance. Sitrof has a proven track record at many Tier 1 and Tier 2 life sciences companies, managing millions of documents across disciplines, departments and external partner ... READ MORE

Marketing & Promotional Material

Managing the creation, approval and final production of promotional materials for the pharmaceutical industry has traditionally been a cumbersome, time-consuming, paper-intensive process. From the initial job request—once the drug name has been approved—t ... READ MORE

Clinical Trials

From pre-phase 1, protocol review through Phase III clinical trials, the need for sponsors to collaborate with external partners—whether legal counsel, CRO, IRB or manufacturer—has become a daily occurrence. Documents such as contracts, informed consent, ... READ MORE

Manufacturing

MSDS Sheets, SOP's and other critical documents need to be kept up to date, easily accessible from disparate systems and departments. Collaboration tools need to be in place in addition to electronic signatures. Let Sitrof's decades of experience with mission ... READ MORE