Product – Promotional Materials Approval System

Managing the approval of promotional activity has traditionally been a paper-based manual exercise. Design, artwork, and copy are passed from department to department to be approved, passed via the traditional ‘job bag’, carried in the ubiquitous brown envelope with signature list attached, moving from ‘in box’ to ‘out box’ through the organisation. With a little luck and a lot of manual monitoring, chasing, and processing, an approvals job may reach its conclusion in time for final sign-off before a print deadline.

With the advent of the Internet and intranet, combined with new standards for electronic documentation, a new approach is possible. Documents can be electronically filed within an electronic approvals system, and then passed via a configurable workflow route past the stakeholders for authorisation. Stakeholders can include entities outside the enterprise such as medical education agencies, advertising and design agencies, and PR companies. Internally the materials must traverse key individuals within Sales, Marketing, and Clinical, often being processed concurrently if filing or print deadlines are to be met.

C&C Group developed PMAS specifically for the pharmaceutical industry but the web-based system has also found a home in organisations such as Cisco Systems who rely heavily on promotional activity to maintain market share. The approval of design, artwork, and copy is not unique to pharmaceuticals, but there are particular drivers within the pharmaceutical domain which make the approval process appropriate for a systemic process-driven approach.

Key drivers include:

• Compliance
  Pharmaceutical companies are subject to significant regulatory and compliance control. Promotional statements can damage a pharmaceutical company significantly if challenged successfully by a competitor or a regulatory agency. Controlling the approval of materials is critical. Upheld competitor challenges can damage market share and even threaten market authorisation status. Accurate and effective control of the approval process is the key to guaranteeing compliance.
  
  
• Timeliness
  Promotional activity is deadline-driven. Targets must be met to securely and reliably approve materials in time for publication or for use in promotional activity such as targeted mail shots. Manual systems often go astray as the job bag arrives in the ‘in box’ of a staff member on holiday, and remains there until the day before a press deadline. The ability to see visualisations of approval routes, and to actively monitor and alert based on approval milestones is key to meeting your deadlines.
  
  
• Collaboration
  Pharmaceutical promotional activity is complex. Product development involves many interrelated business functions (including Sales, Marketing, and Clinical) and the promotional activity required to successfully launch and manage the product portfolio must traverse these business areas. The approvals process is not always linear or sequential; it may have multiple concurrent routes to approval as different business functions approve different sections of the promotional material. Collaboration is essential to speed the approval process. Traditional manual approaches generally support only a lengthy ‘one person per approval stage’ process.
  
  
• Security
  Security is key. The approval of promotional materials often needs reference to share-sensitive information, some of which needs to be attached to the job to ensure that the approval decision is fully substantiated and auditable. Traditional manual systems conclude in filing cabinets full of approval jobs, filed in case of audit by agencies such as the FDA, EMEA, or MHRA. Electronic systems provide a reliable, secure, single point of entry into a searchable archive of approval jobs. Compliance with regulations may mean archives must be held for up to three years, PMAS simplifies this logistical problem by maintaining the archives in a single database.
  
  
• Auditability
  The pharmaceutical industry faces unique challenges with regards to auditability. Promotional activity which uses or makes reference to Clinical data can fall into the ‘validated’ arena. Pharmacovigilance requirements and retrospective reference in the event of adverse drug reactions can often be a key activity in the approvals archiving process. Validated systems are most commonly found in Discovery and Development, Manufacturing, Clinical, and Regulatory functions. The working practises required when developing validated software which can operate in a GxP area are significantly different from those of normal system development. Support for audit trails, electronic documents and electronic signature to the levels described by the 21 CFR Part 11 Guidance (provided by the US Food and Drug Administration) is critical if a system is likely to attract attention from regulatory auditors. PMAS was built with this in mind, drawing upon C&C Group’s pharma division ‘validated systems’ service line experience of developing GxP standard systems in the validated arena such as Clinical and Regulatory patient monitoring systems. A sister product CPEA (Clinical Papers Electronic Archive System) is also available as a plug-in to PMAS, allowing cross-reference between Clinical papers and promotional material.
  

PMAS was designed and built specifically to help pharmaceutical companies answer the challenge of managing, administering, tracking, and analysing their promotional activity approval process. Unstructured processes using insecure combinations of workgroupstyle documents, presentations, and Excel models are re-engineered into a single promotional activity approval process portal. PMAS integrates your approval process within a secure central system, consolidating processes, data, and document management.

Features include:

• Corporate-portal single point of entry to your approvals process database, via Internet, extranet, or intranet deployed feature-rich browser-based interface. No requirement for any PC installation of software. Can be deployed via the extranet to provide access for external suppliers such as advertising and market research agencies, improving communication and increasing efficiency.
  
  
• Extended team-based security model allowing stakeholders to work concurrently on materials approval. Access to specific stages in the approval of a job can be granted at a granular level meaning that multiple stakeholders can work on the same ‘job bag’ concurrently.
  
  
• Sophisticated collaborative features to mirror your manual communications and approvals process. Approvals processes can be created from templates or set up specifically to fit a particular project.
  
  
• Integrated knowledge management features to allow stakeholders to store supporting information (for example competitive intelligence data) in any format; e.g. Word, PowerPoint, Excel, etc. Content can be uploaded and hyper-linked at both ‘job bag’ and granular ‘job bag’ stage level giving you the tools to record the ancillary information around your approvals decision-making.
  
  
• Simple intuitive menus for navigating approval job configuration, based on the web-browser ‘back / forward’ standard for content navigation.

• Ability to define workflow milestones on a ‘per project’ basis, and configure the email broadcast content and recipient lists when milestones are reached. Workflow features allow the clock to be started and for milestones to be detected automatically as the time allocated for the approval of a job elapses.
  
  
• Search screens to identify and view specific archived jobs, criteria includes all free text fields. Optionally the system can ‘mine’ the content of the ‘job bag’ attached documents, or ‘job bag’ stage documents.
  
  
• Email alerting based on event-triggers such as entry of new jobs, or stakeholders being allocated to a job.

• Full audit trails showing approval route stakeholders, their approval activity and interactions with PMAS.
  
  
• Dedicated data-mart fed from the operational PMAS database, and re-orientated into star-schemas to provide analysis on the approvals process.

• Enterprise application integration toolkit (EAI API) via .NET web-services to feed data between ERP / CRM / Clinical systems and PMAS. Can be used to create hyper-link interfaces into external systems which provide supporting information.
  
  
• Best-of-breed technology using robust, scalable (to the 1000s of users), Microsoft .NET web-framework on SQL Server 2000 database.

• Implementation, hosting, support, training, and maintenance services are available.