#pharmaceutical lms

There is greater pressure than ever before to get items to market faster and cheaper. This involves a continuing focus on breakthrough technology, enhanced trial designs, specialized areas of concentration, and better procedures in the clinical research business.

Millions of dollars are spent on these projects and organizational restructuring the future of clinical research industry. While these go-to methods are important, they may not be enough. These tactics are given disproportionately high priority, enterprise energy, and investment. 

People and the setting in which they work - the culture - are undoubtedly the two most important organizational tactics for effecting desired change. Both, however, are either missing or given insufficient attention. Decades of study have shown that these endeavors will fall short unless a significant investment in people and culture is made.

In the future of clinical trials, clinical trial associates stand as the unsung heroes in the pharmaceutical landscape, playing a pivotal role in the development of life-changing drugs and therapies. Their work is often behind the scenes, yet their contributions are fundamental in bringing innovative treatments to the forefront of modern medicine.

As the pharmaceutical industry continues to evolve, the importance of clinical trial associates becomes increasingly pronounced. These professionals are tasked with orchestrating the intricate processes involved in clinical trials, which are the cornerstone of drug development. From coordinating trial protocols to ensuring regulatory compliance, their responsibilities encompass a wide spectrum crucial to the success of new pharmaceuticals.

Consider your own industry experience with initiatives that did not achieve the anticipated, long-term transformation. Was it the procedure, the technology, or the structure? Or was it something else, such as a silo mindset, a blame culture, or another expression of day-to-day work behaviors? 

Let's look at an example. Compare the resources and attention committed to introducing novel technology that influences numerous functions in your organization to the resources dedicated to building people's skills to perform effectively in a complicated study team setting.

Why has the clinical research industry been so hesitant to place an emphasis on people and culture? As future trends in clinical research develop, are we more at ease concentrating on procedure and structure? Maybe we simply need some direction on where to start or how to expand on previous efforts.

This article outlines a strategy for fostering an agile team, being adaptable to change, and cultivating a creative mentality capable of disrupting the industry and the future of clinical trials with respect to technology. It all starts with a recent trend discovered during an industry benchmarking effort aimed at determining how the clinical trial associate (CTA) function fits inside the organisation. The purpose was to learn if the CTA job was centralized (collaborated with functional line managers) or decentralized (reported to trial managers).

According to the benchmarking results, one-third of the firms had an established organizational structure for at least five years, with the rest of the enterprises reorganizing during the previous five years. CTA centralization was part of the redesign for three of the four organizations that were reorganized in the previous year or two.

When asked why they created a centralized CTA function, organizations stated that it was to solve challenges such as:

Siloed Mentality

Consistency and effectiveness

Resource allocation and adaptability

Getting rid of redundancies

While these are valid reasons to promote organizational change, and it is simple to monitor progress, they are insufficient to realize the full potential of centralization.

One of the primary functions of clinical trial associates is to collaborate with a diverse range of stakeholders. They work hand in hand with researchers, physicians, regulatory bodies, and pharmaceutical companies to meticulously plan and execute trials. Their attention to detail is unparalleled as they navigate through complex regulatory frameworks, ensuring that trials adhere to stringent standards while maintaining ethical integrity.

Furthermore, technological advancements have ushered in a new era for clinical trials, and associates are at the forefront of adopting these innovations. Technologies like artificial intelligence, big data analytics, and telemedicine have revolutionized how trials are conducted. Clinical trial associates harness these tools to streamline processes, enhance data collection and analysis, and even optimize patient recruitment, making trials more efficient and cost-effective.

Companies, whether centralized or not, acknowledged two contemporary challenges: recruiting and retention. They also recognized the need to concentrate on engagement and skills. The makeover, which was designed solely for efficiency, exacerbates one of the industry's most pressing issues: recruiting and keeping talent. It's easy to talk about it, but how can we go forward with implementation?

In a sector where upheaval and organizational redesign are constants, investing in CTAs early in their careers will yield a resilient workforce able to take on advanced responsibilities within the organization. This strategy is also more likely to foster functional loyalty while resolving silo mindset issues. 

Investing in personnel also gives a vital competitive advantage by reducing substantial issues with recruiting and enhancing colleague engagement and retention.

The future of the pharmaceutical industry heavily relies on the agility and adaptability of clinical trial associates. Emerging trends such as personalized medicine and gene therapies present novel challenges, and these professionals are at the vanguard of embracing these changes. Tailoring treatments to individual genetic profiles requires meticulous trial design and execution, where clinical trial associates play a pivotal role in ensuring precision and accuracy.

Moreover, the COVID-19 pandemic acted as a catalyst for innovation in clinical trials. The rapid development of vaccines showcased the industry's ability to expedite processes without compromising safety or efficacy. Clinical trial associates were instrumental in navigating the complexities of accelerated trials, demonstrating their resilience and capacity to adapt to unprecedented circumstances.

Looking ahead, the role of clinical trial associates will continue to evolve. With an increasing focus on patient-centric approaches, there will be a greater emphasis on inclusivity and diversity in clinical trials. Associates will spearhead initiatives to ensure representation across diverse demographics, thereby creating treatments that cater to a broader spectrum of individuals.

In Summation

Audit Trail Management is a regulatory requirement in the pharmaceutical industry. An audit trail is essential because it makes electronic data secure and traceable. It helps in keeping track of the name of persons who accessed the computer system with the date and time. It also helps in recovering the lost data. The audit trail maintains the integrity and security of audit records and a pharmaceutical LMS has a role to play here.

FDA has issued numerous warning letters pertaining to audit trails. In pharma manufacturing, the requirements and conditions of the audit trail impact computer-controlled systems. Audit trail management must be performed for all equipment, procedures, and people training in the pharma industry.

Only when these computerized systems do not have the option of data change, audit trail management is not a necessity. But systems like these must be controlled through SOPs which ensure authorized access to the computerized system.

Challenges in Pharma Audit Trail management

Audit Trail Management faces various challenges in the pharmaceutical industry. Many pharma companies rely on manual management wherein records are usually maintained on excel which is not scalable. The FDA has also mandated e-record keeping and e-signatures and discarded the traditional practice of paper-based record keeping because of the inefficiency and manual errors.

Another challenge faced by pharma companies in audit trail management is the lack of a secured system that does not allow any backdated activity and maintains a rigid audit trail for the authorities. Something as seemingly small as putting a backdated signature on a document can lead to compliance failure and huge losses and business risks.

A pharma audit doesn’t just happen for procedures. It happens for each job role related to the procedure, training, process documents, hardware and software, external agencies, changes, and modifications in the process. So, in order to maintain compliance an enormous amount of data has to be tracked and monitored to avoid issues with the authorities.

Importance of a Pharmaceutical LMS in Audit Trail management

A pharmaceutical LMS ensures seamless audit trail management with automated tracking and record-keeping. Automated record-keeping significantly eliminates errors and enhances efficiency. Here are a few essential features of a pharmaceutical LMS that simplify audit trail management for companies: 1. Continuous Tracking

A pharmaceutical LMS ensures continuous tracking of every aspect that will be audited. This ensures a gapless audit trail management which reduces the risk of compliance failure. 2. Data Storage Capabilities

Apart from continuous tracking, a pharma-industry-specific LMS also has amazing data storage capabilities. This makes sure that you don’t have to worry about tracking and storing an enormous amount of data. 3. Secure System

A pharmaceutical LMS only takes valid inputs. No invalid record is stored even temporarily. This includes backdated signatures. This maintains the security of the system. 4. Centralized Data

A pharmaceutical LMS keeps the data centralized which simplifies management. The QMS and DMS are integrated with the LMS to create a single repository of processes, documents, and training related to the same. 5. Custom Report Delivery

The audit trail that is demanded by the auditors has a specified format. A pharma LMS helps you deliver your records in the format specified by authorities with the custom report delivery feature.

To sum up, a pharmaceutical LMS offers various features that simplify audit trail management. With rigid and strict regulations about audit trail management in the pharma industry, a pharma industry-specific LMS is the right choice.