Data Management

Pharmaceutical companies are one of the major beneficiaries of emerging technologies.  From innovative ideas for developing new drugs to customer engagement, drug manufacturers are increasingly resorting to cutting edge digital technology to streamline business and improve efficiency.  Nowhere in pharma is the boom in technology more beneficial than in data management, an area where many drug companies struggle to organize and manage massive quantities of information.

As the regulatory landscape increases in complexity, the demand for improved 

data management and analytics will increase as well.  With all the new challenges that these trends create, digital data management is an innovation that pharma companies should have in their toolbox.

Below are the top five reasons that your current data management system is failing your company: Read More

Recently, in a forum setting, a panel discussion touched upon cost versus price and how best to address the potentially touchy issues of cost versus pricing. With recent consumer outrage over drug pricing and demands for cost controls, this is a hot button issue for both drug companies and the people they serve.
 

A great deal of attention has been placed on the price of drugs; some have even called price increases gouging, but to paraphrase a panel commentator – ‘Beats’ headphones have margins on their products much hihger than pharma and nobody seems to care about that.”  Although this is a true statement, to be fair, nobody’s grandma has ever died without their “Beats.”  Perhaps there is a way to let grandma have her Beats AND her heart medication.  With that statement in mind let’s explore the top three ways to optimize both cost and pricing:  choosing the right CMO, maximizing communication, reducing errors and celebrating innovation.

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A very close and trustworthy colleague in the industry has stated that the magic of the lab is the absolute random, disarray of work that leads to producing the best drugs.  The way that different pharma companies operate during the drug development process and the way they collect, analyze and distribute the data is unique to that company.

Result: The successful drugs we have today.

On the other hand, industry pressure, government regulations and financial responsibilities have pharma looking inward to see how changes in the drug development and manufacturing process can be streamlined and efficient.  A common answer to the problem of efficiency is standardization.  There are multiple benefits of standardized data:  better communication, savings of time and resources, ease of comparison and enhances collaboration between scientists and outside partners.  According to Nicola Tambascia of Clinipace, more regulatory agencies worldwide are beginning to require standardized data as part of the submission process. Read More

“Scientists spend greater than 50 percent of their time searching for data that already exists.”

-Allotrope Foundation

Does your data have a purpose? If not, you may be missing an opportunity–or worse, wasting your time collecting random bits of information. Here are the top five tips to ensure that your data is working for you.

Integrity

Integrity is a key component of putting your data to good use.  Technology has improved exponentially over the years to allow for document organization, data management and overall informatics control.  Control is the key when it comes to data integrity.  The ability to control your data is fundamental in guaranteeing the integrity of your data; a critical component of regulatory submissions and documentation.  Choosing the right tools to control data is imperative.  Not all tools require validation, but a solution should have the ability to trace data for consistent recall for submission and filing purposes.  Control your data and it’s integrity, and you will save yourself untold amounts of time and headache when it’s time to submit your documents.

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In this day and age there are multiple organizations whose sole purposed is to collect, organize and interpret your data.  Data has never been more critical, and the use and interpretation of it become even more important every day.  But how can we capitalize on using every bit of our data to increase our output effectively?

To ensure safety and efficacy, any data associated with a pharmaceutical product must be “attributable, legitimate, contemporaneous, original, and accurate.”

-Darren Barrington-Light, Biopharm International

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I have been reading countless articles and blog posts about the pharma industry’s inability to utilize the data we produce on a daily basis in our development life cycle.  Article after article details how we are not utilizing, optimizing or constructively taking advantage of the benefits the data produces, BUT……

….not one article tells us how.

Let’s look at some solutions to accomplish the task of making your data as effective as possible; in other words, making your data work for you.

ORGANIZATION

“Knowledge workers spend over 50% of their time searching for data that already exist.” – Allotrope Foundation Read More

In efforts to improve efficiency, we often turn to the basics:  cut the time it takes to accomplish the task, cut the cost incurred to complete the project and cut the amount of waste associated with the process.  Unfortunately, as any project manager can attest to, increasing efficiency is easier said than done.  When you have cut your time, costs and waste as much as possible, what is left to cut?

One simple often overlooked approach in improving efficiency is to MANAGE cost more effectively. Read More

Decision-making is a core function of any drug development firm.  Developing drugs demands a firm to be highly innovative, while at the same time the activity is strictly regulated. – Antti Jekunen, NCBI                                                                                             

When moving through the drug development process the high stakes decisions made will save or cost tens to hundreds of millions of dollars.  Making a decision in a timely manner with precision and accuracy is essential to bringing a drug to market.  Pressure from investors, stakeholders, stockholders, and regulators have critically changed the dynamic and pressure involved and still, the pharma industry does not adapt to innovation and maximize available technology.  How many hours are wasted searching through scribbles in random lab notebooks, searching for analytical results scattered across a desk, or hunting for stability results that you know you had in this email somewhere…..

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