Support Services for the Pharmaceutical Management Branch

The Pharmaceutical Management Branch (PMB), CTEP, DCTD provides comprehensive support for the management and distribution of investigational agents for CTEP sponsored clinical trials. This support includes, but is not limited to, acquisition, inventory management, order authorization and record maintenance for all CTEP IND agents and a limited number of commercially available agents distributed under agreements with NCI-specified collaborators. PMB also oversees the distribution of confidential Investigator Brochures for our IND agents. PMB maintains investigator registration documents and continues to oversee the annual investigator registration required for investigators to participate in protocols sponsored by multiple Programs within the DCTD. PMB provides comprehensive pharmaceutical information and pharmaceutical reviews for protocols sponsored by Programs throughout the DCTD. The purpose of this contract is to provide primary support to Government staff within PMB in addition to support across multiple Programs throughout the DCTD. The contractor provides a first and sometimes only point of contact for many of our outside customers working on CTEP sponsored clinical trials. They process electronically submitted orders and e-fax orders for CTEP sponsored trials to insure that the right agent gets to the right site in the appropriate timeframe to conduct the clinical trials. Agent ordering and inventory management is also maintained for a limited number of DCP and CIP clinical studies as well as some limited distribution of commercial agents under agreements with NCI-specified collaborators. Order entry responsibilities naturally extend into managing stock recovery, agent transfers and local destruction of study agents, when appropriate. PMB is currently in the process of enhancing our existing data capture system to a fully on-line web-based system. This transition will start during the current contract with on-line agent ordering and expand over the life of the next contract to include agent transfers, local destruction, stock recovery notifications and potentially on-line agent accountability. While this will eventually reduce the level of need for order entry functions, this role cannot completely be eliminated as PMB must determine which lots of agent can be sent to each particular site. In addition to order processing, the contractor manages the distribution of confidential collaborator documents (i.e. Investigator Brochures). Recently, additional emphasis has been placed on conducting double-blind clinical trials and increasing international participation on CTEP sponsored trials. These two areas of focus involve significantly more complex order processing and require a significantly higher level of effort by both the Government staff and contractor. The contractor maintains the annual registration documents (1572, Financial Disclosure Form, Supplemental Investigator Data Form and CV) for all investigators participating on CTEP/DCTD sponsored trials. The contractor also maintains the Financial Disclosure Questionnaires/Confidential Disclosure Agreements (FDQ/CDA) required for those participating in the Investigational Drug Steering Committee meetings. In addition to investigator registrations, the contract also maintains the registrations and re-registrations for Associates. The contract is responsible for staffing helpdesks for the Enterprise Core Module (ECM) and Identity and Access Management (IAM) programs, which maintain records/accounts for persons and organizations associated with CTEP's clinical research program. The scope of these two activities extends beyond CTEP to also support the CTSU, DCP, CCOPs, among others. Contract staff is dedicated to the administrative support of the NCI's Treatment Referral Center, which assists customers with locating appropriate ongoing clinical trials or potential alternate mechanisms for access to investigational agents (i.e., single-patient protocol, Treatment Referral Center protocol, Treatment Use protocol, and company sponsored programs). The contractor provides direct support to the pharmacists within PMB by providing agent reports, drug estimates and distribution reports upon request. They provide agent distribution reports to CTMB for the purpose of auditing agent records at the site level. In addition to the clinical project support provided on the contract, the contractor is also expected to provide word processing, data entry, photocopying, filing, telephone, scanning and clerical support. PMB will provide space for up to 10 FTE's on-site, currently located at 6130 Executive Blvd, Rockville, MD. The Project Manager and one registration specialist are required to be located at the Government site. In the future, the available space will be provided at the new NCI Shady Grove campus in Rockville, MD. The Government site will include computers, telephone, scanning, fax and copy equipment for use of the on-site staff. The off-site location, mostly consisting of Investigator and Associate registration activities, will be equipped and maintained by the contractor. Recent Project History The current contractor has a proven record of high quality work across the entire spectrum of PMB activities. - triage almost 1600 phone calls and 350 e-mail contacts per month within PMB - process approximately 2100 open-label and 1800 blinded orders per month o 30 international orders requiring additional processing steps and documentation - Stock recovery, transfers, local destruction o Stock recovery ~ 760 per month o Transfers ~ 40 per month o Local destruction ~ 35 per month - Investigator Brochure distribution o ~ 900 brochures per month (mass updates/amendments) o ~ 200 individual requests per month - NCI Investigator registration (1572, FDF, SIDF, CV) o 18,000 + active NCI registered investigators requiring annual updates - IDSC FDQ/CDA maintenance o Averaged 1-2 meetings per month with approximately 30 participants per meeting o In the past year, the FDQ/CDA collection has been transitioned to an annual event rather than per meeting. The information is still being maintained by the current contractor. - ECM / IAM helpdesk o ~ 1000 interactions (e-mail, calls) per month - Audit reports o Average 10 reports per month - Proactively evaluate processes within PMB, provide insight and develop and maintain appropriate SOPs - In addition to the above accomplishments, the contractor continues to expand their understanding of the program and the importance of our mission. The contractor made themselves available via remote access and telephone to assist during the unprecedented snowstorms that hit the DC area. With their assistance, we were able to process time sensitive agent orders, process e-mails and correspond with clinical sites in order to facilitate and continue patient treatment during the localized event