Article 269: The Unexpected Outcomes of 21 CFR 11 Compliance

• The FDA is now handing out more citations for 21 CFR 11 noncompliance than it has in the past. Sponsor companies are scrambling to ensure that they, and their CRO and investigative site partners, are in line. The cost of implementing 21 CFR 11-compliant practices and procedures is projected to be more than double the cost of implementing those for Y2K compliance. In all, industry may spend an estimated $5 billion in implementation costs. 21 CFR 11 is also expected to increase CRO and investigative site costs for training and support infrastructure.

Article 270: Breaking the Development Speed Barrier

• Industry has broken the development cycle time barrier. During 1999 to 2001, total development time per drug (IND approval to NDA approval) came in at 5.9 years. This is well below the 7.25 average cycle time for a drug developed since the early 1980s. The fastest pharmaceutical companies have implemented a wide variety of initiatives from centralized protocol design and patient recruitment to higher levels of e-trials technology use, decentralized field monitors and improved CRO and site selection practices.

Article 271: CentreStage Europe: European Sites Name MDS Pharma, PPD and Covance Best CROs

• The friction between European investigative sites and the CROs that they work with has become quite familiar. As CenterWatch reported a year ago, sites perceive higher levels of inefficiency in the grant payment, contracting and budgeting, and query handling processes when CROs are involved. The results of the 2002 survey of European investigative sites confirm that these areas remain problematic. Sites also report that CROs remain rigid and difficult to interact with collaboratively.

Article 272: Eye On Osteoarthritis and Rheumatoid Arthritis

• CenterWatch Drug Intelligence has identified a sizable clinical pipeline of 48 drugs accounting for approximately $230 million in grants.