Promotional/Medical Review & Approval Solutions


Indegene provides full-spectrum promotional/medical review solutions to pharmaceutical and other life sciences organizations. It offers a modular set of solutions that includes medical review (technical and nominated signatory), editorial services (proofreading and fact check), and operations support (coordination, reference tagging/uploading, and asset management). The Indegene hybrid operating model is simplified, scalable, flexible, and cost-effective and offers shorter time-to-market, minimal compliance risk, and maximized operational efficiency.

Promotional review committees (PRCs) of pharmaceutical and other life sciences organizations are going through a challenging phase. The pressure on PRCs has never been more intense due to the dynamically changing global and regional regulations and stringent guidelines. Latest hearings about First Amendment rights of pharmaceuticals while discussing off-label use have only made the process more cumbersome and difficult for PRCs.

“Promotional material review is an onerous, time-consuming, and multi-stakeholder process, exposing companies to compliance, regulatory, and competitive risks.”

 

Key Challenges in Promotional Material Review:

 

 
INCREASING COMPLEXITY
  • Multiple partners and deliverables for each brand
  • Ability to perform reviews on deliverables of varying complexity
  • Need for review of umpteen number of jobs across various franchises, year on year
 
LONGER TIME TO MARKET
  • Launch of deliverables takes several weeks, with approximately one-third of the time spent on reviews and approvals
  • Hundreds of hours spent in PRC meetings
  • Several calendar days from first submission to market

 
MULTI-STAKEHOLDER PROCESS
  • Apart from the reviewers (regulatory, legal, medical, editorial, and marketing), stakeholders from brand teams and agencies, global, regional, and managed markets are also involved
 
COMPLEX TECHNOLOGIES
  • Off-the-shelf workflow tools need intensive training and are cumbersome to use
  • Frequent reorganizations / restructuring within pharma warrant frequent re-training

 

View from the Medical Affairs Team:

 

 
PREFER A STRATEGIC ROLE
  • Desire to do more value-added work
  • Spend time in building relationships with KOLs and developing market
 
AVOID MUNDANE TASKS
  • Considerable review time is spent in correcting errors in grammar, style, and referencing
  • Wide disparity in submission quality between vendor partners
 
OVER THE FENCE
  • "Gold plating" every asset even if only a cursory review is required
  • Expectation that Medical will identify all errors
  • Onus on the reviewer to ensure all the comments are addressed
Indegene

 

Indegene provides full-spectrum promotional/medical review solutions to pharmaceutical and other life sciences organizations.

“Full-thickness solution provider for simplified and faster time-to-market Promotional/medical review and approval solutions to minimize compliance risk ”

Indegene offers a modular set of solutions that includes medical review (technical and nominated signatory), editorial services (proofreading and fact check), and operations support (coordination, reference tagging/uploading, and asset management). The Indegene hybrid operating model is simplified, scalable, flexible, and cost-effective and offers shorter time-to-market, minimal compliance risk, and maximized operational efficiency.

 

KEY FEATURES

 

 
MEDICAL
  • Data Fact Check
  • Medical Review
  • Nominated Signatory
 
EDITORIAL
  • Proofreading
 
OPERATIONS SUPPORT
  • Marketing Coordination
  • Reference Tagging and Uploading
  • Asset Management

 

Indegene Differentials

 

Expertise
  • Complete understanding of the review process (PRC/CCC/ MLR RC/MARC)
  • Fully conversant with PhRMA (US), Rx&D (Canada), ABPI (UK), and EFPIA (EU)
  • Function-specific proprietary tools
  • Vast talent pool and institutionalized training, knowledge, and quality systems
Experience
  • 35+ years of collective experience in nominated signatory engagements
  • Current engagements with 7 of the top 20 pharmas
  • Extensive experience with Veeva Vault, Aprimo, and Zinc platforms
  • >100,000 assets reviewed with 99% accuracy and 100% compliance per year
Flexibility
  • Mix of FTE or time-material engagements to manage peaks/troughs
  • Onsite or offshore-based staff, as per client requirements
  • Investment ahead of the demand curve

 

Testimonial:

 

“You are a team that has been a joy to work with, and the dedication, diligence, and skill you’ve brought to the job has been fantastic. I have received many positive comments from people in PRA and elsewhere here about how grateful they are for your sharp reviews and detailed accuracy checks, as well as your putting in the extra effort to help asset owners meet deadlines.”