Supply chains integrate the flow of information among internal and external network participants throughout the procurement,
production, distribution, and customer interface stages of manufactured goods. They enable aggressive inventory management,
customized product delivery, and just-in-time manufacturing, which revolutionized the automobile industry. In addition to
a supply chain, the pharmaceutical industry must manage a value chain: the procurement, production, assembly, and distribution
of data. Data shapes the path from a "hit" in the discovery process to a label claim on a package insert. This value chain
is at the core of pharmaceutical development. This value chain has been managed in the past by legacy processes and a few
modern systems. Clinical development, the final common pathway of all potential new medicines, is beginning to wake up to
the need for an optimized value chain.
Linking supply chains and value chains can spur the drug development process. Consider, for example, the supply problems in
clinical trials of new biologics, especially when drugs are manufactured in pilot plants. Often, the supply and stability
of a study drug from such plants are very limited, leading to delays in starting crucial Phase II clinical trials. There simply
isn't enough study drug available to leave a supply at every investigative site for months, while the sites wait for new patients.
By linking the EDC system with fulfillment data, sponsors can have a study drug shipped overnight to clinical sites as patients
enter a study.
Global regulatory changes are driving the move to EDC technology. In 1997, when FDA issued 21 Code of Federal Regulations
(CFR) Part 11, the Electronic Records, Electronic Signatures Rule, the agency began to create an electronic regulatory environment.
Since then, FDA has established the Data Standards Council to coordinate the use and maintenance of common regulatory data
standards throughout the agency. For data interchange and archiving, the agency now uses standards developed by Clinical Data
Interchange Standards Consortium (CDISC). It has named CDISC's Study Data Tabulation Model as a standard format for data submitted
in product applications. FDA plans to require electronic data submissions for NDAs, amended new drug applications (ANDAs),
and BLAs. Also, FDA is now accepting electronic patient-reported outcomes (ePRO) from wireless handheld devices.
The Role of EMR
The electronic regulatory environment was expanded when The International Conference on Harmonisation (ICH) created the electronic
common technical document (eCTD), a new version of the CTD, which contains information about the safety of a product. The
(paper or electronic) CTD is required in Europe, and FDA strongly encourages its use, especially in online applications. According
to the ICH, the eCTD should serve as the basis for the safety issues identified in the Pharmacovigilance Specification—a summary
of the identified and potential unidentified risks of a drug.
And there are more developments. In March 2005, FDA issued Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment,
an industry guidance for detailing safety signal identification and development of a pharmacovigilance plan. According to
the guidance, sponsors may want to consider developing electronic registries, which are organized systems for the collection,
storage, retrieval, analysis, and dissemination of information on individuals exposed to a specific medical intervention.
By creating registries, sponsors would be able to evaluate safety signals identified from various sources, and analyze factors
affecting the risk of adverse events.
Still on the subject of safety, the European Medicines Agency (EMEA) now requires sponsors to submit data electronically on
suspected unexpected serious adverse reactions (SUSARs) to EudraVigilance, the European data processing network. EudraVigilance
has enabled EMEA to implement electronic data exchange of Individual Case Safety Reports (ICSRs) on marketed products, using
data standards outlined in ICH guidelines. In addition, EMEA requires sponsors to make electronic submissions to the European
Clinical Trials Database (EUDRACT), a clinical trial registry.