Biotech: How to Digitise the Paper Trail

More corporate executives in large pharmaceutical companies as well as up-and-coming entrepreneurs with start-ups are finding out that there needs to be a clear high-level strategy to embrace the concept of establishing secure electronic repositories for data collected in all phases of pharmaceutical drug development and bio-medical studies.

This is becoming a major concern to those in an industry who have shuffled papers, clinical notes, lab results and used data entry for years between different stages of a product launch from initial research and development, to licensing, lab testing, clinical trials, patient testing, regulatory filings, and manufacturing and distribution of the product.

There needs to be a cross-pollenisation of highly reliable, secure, scalable systems that are already in use by other industries. These systems are platforms of proven technologies for the organized storage and keyword retrieval for intellectual property as well as clinical data and client results that are gathered and consolidated throughout the product lifecycle.

In other words, now is not the time to re-invent the wheel (in this case, the system) that has to capture all of this information and store it in some type of format that it can be easily retrievable for future use. Now is the time to look at systems that can provide a clear retrievable access methodology to any phase of information that has been collected and recorded over a period of years.

Any technology, no matter what it is, steps though the Five Levels of Technology which I have defined in an earlier white paper (“Aiming for Quality in Technology Investments”) as Embryonic, Proven, Accepted, Safe and Obsolete. Level one is Embryonic and that is the first level of technology. There is a lot of risk in accepting technology in this first level but it also provides the highest competitive advantage when implemented correctly.

The second layer is the Proven layer of technology. This is where the “Embryonic” technology has been proven out in one application, so it falls into the next layer. The third layer is “Accepted” as it becomes more accepted and utilised throughout the industry as well as other industries.

The last two layers of the Template are “Safe” and “Obsolete”. A “Safe” technology is one that is not going to give you real competitive advantage. An “Obsolete” technology actually puts you in a disadvantage because it is obsolete but you are still supporting it with money as well as corporate resources and there is no payback.

Good companies will try to take money spent on Obsolete and Safe technologies and re-apply it to newer technologies that will give them a competitive advantage in filing with the Food & Drug Administration (FDA) for new drugs, their approval and clinical studies.

Cloud computing could be an answer

Some have latched on to the current buzzword of “cloud computing” or “Software As A Service” (SAAS). This could be an answer for some companies, but one thing executives and entrepreneurs must understand about technology is that there is no such thing as a magic silver bullet or “universal solution”. What works for another company down the street, may not work in your environment.

These new approaches have to be carefully reviewed and some due diligence has to be performed before selecting any strategic tool. The fact that the tools are available doesn’t mean they are an automatic fit for every drug development environment.

The three R's for systems

Any system used for pharmaceutical data as well as intellectual property data collection and retrieval must adhere to the Three Rs: Reliability, Redundancy, and Reduced Operating Costs. All of this adds up to a Resilient system which is needed in the competitive environment the pharmaceutical and bio-tech industry is in.

CARLINI-ISM: Taking something that has been proven in another industry and applying it to another industry can accelerate the solutions to both simple and complex problems.

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