The last 25 years has seen the advent of “high-tech” medicines marketed to small numbers of clinicians managing rare conditions. A clinic with tens of patients, controlled by a single specialist, can represent 50% of a national market share with consequent implications for relationship building, added value and opinion leader strategies. During this period regulatory requirements have increased and treatment budgets become subject to more stringent controls so that funding bodies now require proof of both initiation criteria compliance, and ongoing clinical effect. For high value markets influenced by key opinion leaders, fulfilling their need for an electronic health record has provided a contact platform, source of large cohort real world data, and the opportunity for clinicians to examine their own practice more closely.
The relationship between database applications and strategic marketing initiatives is summarized below.
| Phase III & Pre-Marketing |
Launch | Growth | Maturity | |
|---|---|---|---|---|
| Application evolution | Clinical Trial | Post Marketing Surveillance | Electronic Patient Record & Reporting tools |
|
| Strategic Imperatives |
Reduced time and costs to bring NCE to market, Increased process control; Data source focus for Key Opinion Leader programme | Market creation and customer relationship tool | Market expansion; Defence of Market share | Efficient prediction & organisation tool for line extensions & Substitutions |
| Pharma Company Needs and Activities |
GCP compliance; Data Protection, Provenance & Quality; Multi-centre & shared care Multi-national electronic data collection; Language translations Minimal training required for time efficient data entry; Centralised system maintenance Clinical board formation to analyse data and present new findings leading to Publications strategy & Symposia post-launch |
Transfer of trial patients to purchased treatment; Identify CT excluded patients who fulfil license criteria New prescriber / patient Hunting activities; Relationship contact platform; Proof of commitment to disease area |
Increasing focus on clinician’s needs, added value; line extensions | Hunting to Farming transition; product succession planning |
| PC PAL Solutions |
GCP standards: Single and related field validations; Audit trail; E- sign with change control & re-sign of submitted data; Data protection to FDA CFR 21, part 11; Secure access to patient records from any pc; Share patients across centres | Examples of strategic tool uses Clinic level Audits quantifying:
Data Entry Warnings:
High Utility Flexible Systems allowing:
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