"We believe that both technologies are important to risk mitigation and effective trial management. Why not consider them complementary rather than adversarial?"
- Jeff Bertrand

When I go to industry conferences, there is a lot of interest in using Smart Phones and other electronic technologies to reduce trial cycle times and make the patient experience better. In fact, I often hear some big pharma executives talk about all the e-label programs (41 E-LABEL experiments in progress according to them) in development with such glee in their eyes. We understand all the excitement. There are so many exciting possibilities. But, the elephant in the room is the fact that privately many of those involved in clinical trials are concerned about all the "unknowns" regarding the use of new technology. The pharma industry is very risk adverse. The last thing any clinical team wants to face is something unknown that risks the successful completion of the trial or worse yet, risks lives.

Many of the exciting possibilities of technology can be made less risky by combining printed media with it. 

Drug companies use a layered approach to anti-counterfeiting strategies because one solution is never enough. Why can't booklet labels and Smart Phones be complementary to each other to attain a more robust approach in clinical labeling? For example, the critical information could be detailed in a booklet label while additional information/monitoring could be handled by the Smart Phone. In another example, a "nearfield" communication between a Smartphone and an expiry date label could accompany a multilingual booklet label. Both technologies have great advantages and are often stronger when combined.
 

BOOKLET LABEL ADVANTAGES

• 40 years of successful implementation in clinical trials. Well tested. (Total history)
• Patient information is AFFIXED DIRECTLY to the product package not multiple steps away. You have provided the patient with a HARD COPY of the vital information. 
• The patient doesn't have to be tech savvy to use it. Some older patients may feel more comfortable with booklet labels rather than using a Smart Phone.
• You don't have to validate (test) an expensive, complicated network to use them. 
• May provide better legal protection (opinion not legal advice)
• When you factor in the costs of validating and testing electronic networks, booklet labels are a cheaper, simpler solution. 
• They don't use batteries.
• They don't break. 
• They won't have a catastrophic malfunction during a trial. 
• They can't be hacked. 
• Everybody can use them. 
• They may be the best legal defense because they are affixed directly to the product package. 
• A simpler presentation that guarantees success. Complexity creates more issues. 
• Expiry dates can be changed without having to change the whole label. 
• The printed variable codes are printed with resin ribbons and virtually indestructible.

E-LABEL ADVANTAGES
 

• More information is available to the patient. 
• More engagement with the patient which includes patient monitoring.
• Information is updated faster.
• Ability to change expiry date without repackaging/removing labels (if you are allowed by the overseeing regulatory body to use an electronic expiry date.
• (Note of caution) - If an electronic change of expiry is done, verification has to be rock solid or you may be open to legal/government issues.
• Less labeling costs- no relabels, return shipping, etc although the cost may be shifted to the network/computers for validating and testing.
• Presumably less lead time (time might be added back to the equation with network/electronic issues.)
• Larger fonts.

COMPLEMENTARY EXAMPLES

• Bar code plus a booklet label to bring patient more information. (simplest elabel combination)
• Expiry date panel plus a booklet label changed by Smartphone.