What is Sample Management in the Pharmaceutical Industry?
Pharmaceutical sample management involves a precise integration of storage and fulfillment services, all designed to package and ship drug samples, starter kits, and medical devices direct to health care providers (HCPs), as well as sales representatives, field agents, brokers, and patients. Because this COVID-19-era causes lightning-fast shifts in Federal and state regulatory practices, managment requires a high level of expertise and organization to ensure that pharmaceutical samples are handled correctly, accounted for, and distributed in a timely fashion.
At the Heart of It: Compliance & Accountability
A reliable third-party provider (3PL) who manages pharmaceutical sample fulfillment must comply with regulations stipulated by the Prescription Drug Marketing Act (PDMA), the Drug Enforcement Administration (DEA) Controlled Substance Act, and the Food and Drug Administration (FDA). In addtion, direct contact with patients requires HIPAA compliance.
Compliance is a single word that involves many moving parts. For example, areas of scrutiny include warehousing, packaging, shipping, receiving, and storage. Therefore, all actions, processes, and environments must meet a set of standards (which are subject to change). The following are just a few areas of compliance along the supply chain:
• Facility Licensing
• Facility Temperature Mapping and Monitoring
• Facility Security
• Facility Cleaning
• Facility Pest Control
• 21CFR11 Compliance
• PDMA practices aligned to DTP sampling
• Recipient State License Verification to include State, DEA, and Ohio TDDD.
• Verifiable Delivery & Receipt
• Inventory Reconciliation
• Incident Reporting – Theft, Loss, & Shortages
• Appropriate Labeling
Accountability is the process by which the complete journey of the pharmaceutical sample along the supply chain is visible and accessible through data. A system for managing recall notification and recalls is critical to the accountability process for pharmaceutical sampling. Also, a clear method for reporting is essential. Therefore, the best pharmaceutical sample fulfillment teams are proactive in their housekeeping, and are as prepared for a surprise audit as they are for a typical workday.
Product-Sensitive Warehousing & Fulfillment
Covering 500,000 square feet, our facilities at CCG Marketing Solutions feature cGMP storage, meaning our secure, temperature-controlled dedicated warehouse can safely and appropriately store pharmaceutical samples with different environmental needs. However, temperature and humidity are not the only criteria for compliance. In addition, specific standards must be met for sorting and segregating products, packaging, labeling, and kitting.
Also, effective cold chain distribution mandates that pharmaceutical products be kept in environmentally appropriate 2-8 degrees Celcius.
Along with regulations, the market changes quickly, too. Therefore, businesses need efficient and timely pharmaceutical sample management that bends to the market. To this end, we build comprehensive and nimble technology platforms that adapt and grow when conditions shift. CCG’s in-house development team creates customized platforms from a technology stack that include:
• Sample Allocations
• Sample Distributions
• Collateral Ordering
• HCP Ordering Portals
• Integrations with Most SFA Vendors
Technology works best when paired with a high level of personal service. In addtion to an efficent and flexible tech platform, a management plan incorportes communication tools for customer relationship management (CRM) and field sales representative and HCP support.
Industry-Specific Expertise in Pharmaceutical Sampling
In 2005, CCG saw a need for reliable and accountable pharmaceutical sample fulfillment. So, we made a deep commitment to offering the most comprehensive and flexible services in the industry. Today, we build integrated technology platforms that configure to the specific needs of our clients in the pharmaceutical industry. Because pharmaceutical sample management is complex, we simplify the process with consolidated data, streamlined ordering, state-of-the-art warehousing, and a highly trained fulfillment team—all PDMA, DEA, FDA, OSHA, and HIPAA compliant.
CCG Marketing Solutions is the service-oriented management team of choice for pharmaceutical sample fulfillment. Contact us to learn more about integrated literature, customized printing, and sales training materials.