Federal Pharma^®    
Where insight takes form.

At Federal Direct, understanding the processes pharmaceutical companies undertake is all in a day's work. And thanks to that understanding, we've created Federal Pharma^®, a division dedicated to providing you with a single, automated source for flawlessly printed and constructed Case Report Forms and Sample Receipt Forms.

Case Report Forms

Clinical Trial Investigators have enough to think about without having to deal with late or inaccurate Case Report Forms deliveries. At Federal Pharma, we understand the importance of the First-Patient-In date. Every person from our design staff to the shipper works together to ensure timely, accurate delivery of Case Report Forms and related materials to Investigators.

Employing digital on-demand printing technology, Federal Pharma generates more than 60 million CRF impressions annually with virtually unlimited scalability, and provides customers with a suite of Web-based CRF ordering and project tracking tools. These intuitive, easy-to-use systems deliver your data to Federal Pharma, where our expert design, data processing, and quality control personnel transform it into precise, customized documents.

In addition to CRFs, our complete printing, bindery, and finishing capabilities allow you to easily incorporate ancillary components such as calendars, diaries, Vaccination Report Cards, and Adverse Experience Forms into your shipments. And our extensive knowledge of shipping and distribution helps us deliver your CRF order on time, even when international customs requirements come into play.

What's more, Federal Pharma offers an organization flexible enough to handle your most urgent assignments. As a result, Case Report Forms from Federal Pharma arrive accurately, efficiently, and with enough breathing room to make the First-Patient-In date just another visit.

Sample Receipt Forms

Today, the distribution of sample drugs to physicians stands among the most heavily regulated activities in the pharmaceutical industry. At Federal Pharma, we understand these regulations, and create Sample Receipt Form solutions to help keep your processes in compliance.

Designed to make your PDMA compliance as easy as possible, our automated, paper-based sample accountability systems have set the industry standard for more than 20 years. In fact, we've installed more than 30 SRF programs - supporting over 40,000 representatives - at many of the world's leading pharmaceutical companies.

Our Web-based and IVR solutions make ordering SRFs a breeze for your sales representatives, through our Integrated Sample Accountability Systems (ISAS^®) platform, which seamlessly integrates with your internal systems. ISAS is a wrap-around, process management system that lets us maintain and manage diverse program and data elements simultaneously. It gives us the ability to consistently and accurately control confidential data - and then integrate that data with multiple, in-house manufacturing operations, automated shipping and tracking systems, and quality control procedures.

ISAS provides your representatives with multiple Web-based and IVR ordering methods. Representatives can also order materials through e-mail, via fax, or by using FTP, VPN, Cyclone, or any proprietary secure file transfer protocol. Plus, our systems include applications that allow you to order SRFs by Quintile, Decile and other Call Frequency Models.

These materials are all produced in one location through a single point of contact, and help make your compliance efforts more efficient than ever before:

• Uniquely numbered SRF/SDFs, personalized with representative, physician and drug information.
• 48-hour replenishment delivery to field reps with track and trace technologies and rapid response to rollouts and territory realignments.
• Validation or update of address, territory and sales group information.
• Compliance audits of physician rosters.
• Assignment files of unique consecutive numbers by user for data capture validation.
• Required reports including inventory utilization and expense allocation.
• Centralized billing with comprehensive expense distribution.

To ensure your SRFs are flawless right out of the box, we employ an exacting set of quality control procedures, including:

• Master forms created for inventory during program design stage.
• Validation or update of rep information during order processing.
• Electronic and/or hard copy proofing of form images and data.
• Quality assurance inspection for each manufacturing operation.

Our complete design, manufacturing, and integrated distribution services ensure your SRFs are delivered accurately and on time, no matter how tight the deadline. In fact, our large-scale shipping systems fulfill thousands of orders each day.