An efficient publication management process is critical for medical affairs teams tasked with bringing a drug to market. Yet, many companies continue to rely on decentralized tools like Excel and Outlook to manage key aspects of this process. While these familiar tools might seem low-risk and affordable, they come with practical challenges that can hinder growth and compliance risks that could result in delays or penalties.
Explore the strategic dangers and day-to-day hurdles of manual publication management and learn why automation is the key to unlocking growth, innovation, and compliance in the life sciences industry.
Strategic risks of manual publication management tools
Clinging to outdated manual tools for publication management in the fast-paced life sciences industry isn't just a matter of convenience – it carries several profound strategic risks:
1. Cost escalation
Inefficiencies and errors caused by manual processes can lead to higher operational costs due to increased labor hours and rework, not to mention potential fines stemming from compliance violations. The company may also need to invest in additional resources to manage the growing complexity of the publication process.
2. Missed opportunities
Inaccurate or delayed publication submissions can lead to missed opportunities to present research at conferences, submit articles to prestigious journals, or engage with key stakeholders. These missed opportunities can impact the company's visibility, influence, and ability to drive innovation.
3. Delayed time-to-market
Inefficiencies in the publication management process can lead to delays in getting research findings published. These delays can slow the dissemination of critical information to the medical community, regulatory bodies, and other stakeholders, potentially slowing down the development and adoption of new drugs or treatments.
A study by the University of Texas at Austin found that drug approval delays can cost life science companies an average of $1 million in revenue for each day a drug remains in limbo.
4. Reputation damage
Inaccurate or delayed publications, compliance issues, and inefficiencies can tarnish the company's reputation within the industry and among peers, potential partners, investors, and patients. A damaged reputation can undermine the scientific credibility and impact of the company's work, as well as impact the company's ability to secure future funding, partnerships, and collaborations.
There’s no better example of this than the FDA’s accelerated approval of Alzheimer’s drug Aduhelm. Insurers refused to cover the drug's $56,000-per-year price tag due to lack of evidence in their research that demonstrated the drug actually helps slow deterioration of patients’ mental faculties.
Tactical obstacles of manual publication management tools
These strategic risks don't exist in a vacuum; they stem from the tangible issues faced during the daily grind. Let's explore how the practical, day-to-day obstacles inherent in manual publication management tools create and amplify these strategic risks.
1. Manual data entry
The life sciences industry thrives on precision, accuracy, and timely dissemination of critical information. However, when manual data entry becomes the linchpin of your publication management process, you introduce an element of uncertainty and inefficiency that can have far-reaching consequences.
Why is manual data entry bad news for publication management? There are two key reasons:
- Increases risk of error: Manual data entry and copying and pasting between tools increase the risk of errors. Even small mistakes in data entry can have serious consequences when it comes to the accuracy of publications.
- Poor use of resources: Manual processes and tools are resource-intensive and consume valuable time and labor. Rather than research professionals spending excessive time on time-consuming administrative tasks (such as entering data into Excel spreadsheets or manually consolidating review feedback from multiple reviewers), this time could be better spent focusing on higher-value research tasks such as analyzing data, strategizing, and contributing to the content itself.
At LimFlow, an early-stage life sciences company specializing in treatments of critical limb-threatening ischemia (CLTI), Director of Medical Affairs Cecilia Petrella was grappling with just this very challenge. The manual, time-consuming effort of managing publication reviews was pulling Petrella’s attention away from higher-level strategic projects.
"If we had ten reviewers providing feedback on a single publication, that meant there were ten versions of the publication that needed to be reconciled," Petrella explains. "Manually combing through each version and reconciling all the feedback into one cohesive document requires a lot of time and effort on our part."
To solve this problem, LimFlow implemented PubPro, a publication management system that enabled multiple reviewers to work on the same document simultaneously.
2. Lackluster process visibility
Process visibility is vital at all levels of the medical affairs department — from the tactical day-to-day level of managing the back-and-forth of publication review to the bird's eye 10,000-foot view that provides leaders with insights and data to make informed strategic decisions.
Let's dive into the hallmarks and risks of a publication management process that lacks visibility:
- No automated workflow routing: Reviewing and approving publications often involve multiple rounds of feedback and revisions. Manual tools lack automated workflows for routing documents to the right stakeholders, resulting in delays and potential oversights in the review process.
- Rudimentary or non-existent version control: Managing versions of documents becomes challenging without a centralized system to track changes and maintain version history.
- Creates data silos: Manual tools are often isolated from other systems used within the organization, leading to data silos and duplication of efforts. Information can be scattered across different files, folders, and email threads. These data silos make it difficult to keep track of important details such as publication status, deadlines, and author contributions.
- Limited process insights: Managers and stakeholders need visibility into the publication pipeline to make informed decisions and allocate resources effectively. Manual tools offer limited reporting and analytics capabilities, making it difficult to assess the progress of different publications.
- Limited scalability: As a life sciences company grows and handles more publications, the limitations of manual tools become more pronounced. Managing a larger volume of publications with manual tools becomes increasingly challenging and inefficient.
3. No auditing features
Compliance is king in highly regulated industries like life sciences. Publication management processes that lack auditing capabilities pose serious risks:
- Compliance violations: Regulatory bodies such as the FDA have strict guidelines for publication and data reporting. Non-compliance with regulatory requirements, industry standards, and internal processes can result in serious legal and financial consequences. Excel and Outlook do not provide the necessary security measures and audit trails to ensure compliance with industry regulations.
- Data security risks: Decentralized tools lack the security measures of dedicated software solutions, increasing the risk of data breaches and loss of sensitive research data.
Why automated publication management solutions matter
While Excel and Outlook have their uses, relying on them for complex publication management in the life sciences industry is a recipe for setbacks and missed opportunities. The practical challenges of version control, auditing, data entry, process visibility, and workflow routing all have tangible impacts that can result in cost escalations, missed opportunities, delayed time-to-market, and reputation damage.
To overcome these challenges and reduce business risks, life sciences companies should ditch the use of manual, decentralized tools and invest in a dedicated publication management software solution such as PubPro.
PubPro is an automated publication management system equipped with outstanding version control, robust auditing features, automated workflows, and analytic tools that offer several key benefits:
- Enhanced efficiency: Streamlined workflows and reduced data entry tasks free up time for high-value activities, accelerating publication timelines.
- Error reduction: Automated data entry and version control mitigate human error, ensuring accurate and reliable publications.
- Seamless collaboration: Dedicated software fosters smooth collaboration, allowing stakeholders to access, review, and contribute to publications in a centralized environment.
- Risk mitigation: Compliance features and alerts ensure adherence to industry regulations, minimizing the risk of fines and reputational damage.
- Resource optimization: By automating manual tasks, companies can reallocate resources to research, development, and innovation.
From Excel to excellence
By embracing the power of specialized software solutions like PubPro, life sciences organizations can not only streamline their publication management processes but also advance scientific knowledge and improve patient outcomes.
Request a demo of PubPro today.