Biopharmaceutical and medical device product development is increasingly complex and expensive. The FDA, advocacy groups, the media, and the public keep a close eye on the clinical research organizations (CROs) that kick-start the process.  In addition to responding to the watchful eye of those segments, today's CROs operate on an international scale, conducting trials in multiple countries at once, under the supervision of multiple regulatory bodies. The result? These organizations have become a cornerstone of research enterprise, adhering to the highest standards of scientific quality and medical ethics.
 
The complexity of conducting clinical studies has grown considerably over the past 30 years, driving a steady increase in the number of procedures needed for each clinical trial.  This, in combination with increasingly stringent regulatory parameters (such as 21 CFR 312.52, 21 CFR 50, 56, 312, and 812, international regulations, Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards), has moved CROs to begin adopting a complete electronic information environment, gathering and reporting data through secure online channels.  Besides reducing errors, electronic tools speed information-gathering and reduce the need for paper documentation.
 
A contract organization shares the sponsoring company's ultimate goal, which is to manufacture safe, reliable, and effective products, year after year.  However, many CROs today are challenged with inefficient quality systems requiring tremendous man-hours in administration (distributing critical documents and changes, obtaining approvals, etc.)  and disconnected processes that can cause delays and poor results.  Through its electronic enterprise-wide solution, Pilgrim Software aligns with the sponsor and CROs goals to help consistently attain:

• Higher levels of access and visibility into study execution – to assure issues which may be cited during an FDA inspection are identified and can be corrected prior to an FDA visit.
• QA/QC and GxP assurance - to assure adherence to company and institutional standard operating procedures, compliance with FDA Regulations, GCP Guidelines and protection of human research subjects.
• Information security and audit traceability - to assure compliance with organization standards and FDA regulations and guidelines.
• Early warning of safety or other issues – to can help prevent recurrence of noncompliance findings and vastly improve the overall conduct of clinical trials.

Pilgrim’s solution assures that there are linkages between processes, safety and quality systems, and across multiple departments within a clinical research organization.  The software interfaces with a CRO’s internal systems (including ERP/MRP, MES, HR, CRM, PLM and PDM), to ensure that compliance and quality are part of the entire operational management. The result is streamlined decision making, lowered costs for bringing new products to market, and the elimination of complaints and potential trial failures.