Monthly Archives: December 2016

So, You’re Now Under A CIA. How can the Medical Information function help?

According to the last DIA MedComms, March 2016 in Orlando, Med Info Departments within companies that have recently gone under CIA can help their companies adjust to the new level of scrutiny in several ways. 

First, by ensuring CIA Compliance. 

Med Info CIA requirements include maintaining a robust database documentations requirements such as name, nature and topic of interest, exact language used in inquiry, name of sales rep, evaluation of off-label inquiry, nature and form of response, etc. 

Most companies seasoned in MI practice generally use a program, such as IRMS or other content manager to accomplish this, but under CIA, it time to step up your game and train team members to not skimp. 

Finding a standard training plan that works can be complicated, but it doesn’t have to be. Consistency and harmonization are key. RxER helps companies design these training and operational plans.

Second, performing a quarterly analysis of inquiries.

Performing a quarterly analysis of inquiries can help retrospectively drive continuous improvement.

  • inquiry reports for each therapy area

  • sales reps with the most number of inquiries for each product and assessment of off-label requests generated by sales rep by geographic area

This can lead to separate reports that provide valuable insights to the organization and can be of great use to MA TA teams as well as field medical teams. 

Finally, there are other policies to consider revamping, including: 

  • what type of medical information can be distributed

  • how to respond to off-label requests

  • internal review process of responses

  • how sales reps and other medical personnel handle off-label requests

  • submission of product information to compendia

  • HCP signatures for rep-facilitated questions

 If your company needs help developing SOPs, or needs a second pair of eyes to review and revitalize your department operations, partner with us to get you compliant quickly. 


The Multifaceted Medical Information Department

It pains me when I hear, “How can you help make my Medical Information (MI) department become more strategic”. 

I already begin to picture disheartened pharmacists and physicians who are seen and rarely heard, performing a functional role like a vending machine. I come in to consult, assess and analyze what are they currently doing and then show them the missing pieces.

The pain leaves, when enlightenment takes place.

What does an MI Department do?

The MI Department is typically known for responding to inquiries, writing standard responses, going to lunch and leaving to go home. Even in mid-sized to large companies, the MI manager is typically a well-trained PharmD in the US, or a pharmacist or physician in ex-US markets. These highly trained, medical professionals can get disheartened when the workload is high, ideas are undervalued and communication and interaction with the departments they support are low.

Outside the US, when volume inquiry is ramping up, a multitude of other departmentally related tasks can be initiated creating a model of operational excellence.

In reality, the MI department is a vital and strategic force that can be leveraged so effectively for the success of the business. 
Bringing order into chaos and communicating strengths and ability cross-functionally is key.

What types of activities does the MI Department perform? 

The Medical Information role is not limited to inquiry management but includes the following types of activity categories 

  • content generation

  • content development

  • MLRC review and support

  • dossier leadership

  • compendia or PI review and content generation

  • insights reporting

  • monthly or quarterly inquiry analysis and reporting by Therapy Area

  • meeting support

  • TA Strategy support

  • vendor and call center management

  • TA expertise

  • custom response generation

  • spontaneous event and crisis support

  • launch support

  • fields medical team training and support

  • sales team training and support

  • globalization compliance

  • and so much more... 

Email us at to set an appointment to help bring your launch activity chaos into order with Medical Information consulting and outsourcing. 


We can help you build a department from scratch or get the support you need to be more strategic and value producing inside so you can focus and streamline staff to be lean, organized and high performing.