Friday 29 December 2023

Clinical Trial Associates and the Future of Pharma


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.

By Hiren Thakkar

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

In conclusion, the indispensable role of clinical trial associates in shaping the future of the pharmaceutical industry and the future of CTMS cannot be overstated. Their dedication, attention to detail, and embrace of innovation are pivotal in advancing drug development and improving global healthcare. As the industry progresses, these professionals will remain the linchpin in the journey toward groundbreaking medical advancements, paving the way for a healthier future for generations to come.


About Author

Hiren Thakkar, Managing Director, Octalsoft

He is dedicated to empowering businesses to achieve their goals through innovative and cost-effective solutions. He has a unique ability to implement simple solutions for even the most complex problems. With extensive experience working in several industries, including more than a decade in pharma and clinical research, he’s not just an expert but a visionary who understands the potential of technology and knows how to leverage it for clients’ success.


Pharmaceutical Microbiology Resources (

Thursday 28 December 2023

Not all plate counting technologies are the same


While rapid microbiological methods have advanced, most microbiology laboratory tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns to the extent that the U.S. FDA Q&A document on data integrity recommends “double plate counting” using two independent analysts. Issues with plate counting such as the following occur periodically in FDA warning letters.


Not all plate counting technologies are identical and some struggle with mixed cultures or growth effects that lead to merged colonies. What is important is the appropriate selection and qualified adoption of automated digital capture colony counters within the pharmaceutical microbiology laboratory.


This article considers how such devices can be qualified and how data integrity concerns can be addressed.



Sandle, T. (2023) Not all plate counting technologies are the same, Outsourced Pharma, May 2023:


Also in:


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Pharmaceutical Online:

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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Wednesday 27 December 2023

The Role Data Management Plays in the Healthcare Field


What is Data Management


Healthcare organizations use data management to obtain, organize, and use data in an efficient way. Data management is a necessary way of doing business across many industries, and this is especially true for the healthcare industry. Data can affect medical outcomes, research, and the ability for healthcare organizations to operate smoothly. Data management covers a wide range of activities in healthcare. It covers administrative processes, health records, and clinical trials. The healthcare industry has to rely on management processes that can keep data secure, accurate, accessible, and available at all times.


The Role Data Management Plays in the Healthcare Field


Data management plays an important role for collecting and maintaining electronic health records. Healthcare providers have a need to quickly access patient information. Every healthcare department must also have access to the very same information to ensure the system runs smoothly. Clinics, hospitals, and pharmacies all share the same responsibility of providing patients with the best services possible.


The same holds true for research departments. Research departments depend on accurate and timely information, and there are huge amounts of data to consider. This includes treatment outcomes, patient therapies, and demographic information. Its easy to understand why managing healthcare information properly is so important. A failure to manage healthcare data can cause numerous problems.


The Dangers of Not Managing Healthcare Data


A patients privacy and keeping sensitive healthcare information is always important, especially considering how sophisticated cyber threats have become. Healthcare organizations should always plan their security measures to protect against theft of critical and private information. Security breaches can affect treatment decisions, which can directly harm patients. Poor management of data can also lead to legal troubles for a healthcare organization.


Unfortunately, poor data management is often a common problem in the healthcare industry. Faulty information can lead to disrupting urgent care for patients. It can also lead to patients receiving the wrong medications, or not receiving needed medications at all. 

Misinformation can also cause healthcare workers, along with patients, to become frustrated and lose trust.



Everyone has to trust the healthcare system for it to work properly. Once the system falters, a downward spiral might occur if employees have to resort to manual reporting and analysis. Around 38 percent of healthcare organizations currently have faulty data in their systems. This makes healthcare difficult to manage in some instances. Fixing these issues is time consuming and costly, and its difficult to identify proper records when the system doesn't work. Its also nearly impossible to ensure that records across the system are accurate and reliable.


Making the Right Policy Decisions


With massive quantities of healthcare data that grows daily, policy decision makers must have reliable information to make the right business choices. If theres a backbone of modern healthcare, data management fits the description. Healthcare and digital technologies will continue to evolve, and the need for reliable data management will always remain critical. Neglecting data management can impact patient safety, and endanger an organizations finances.


Written by Taylor McKnight, Author for CMIT Solutions


 Pharmaceutical Microbiology Resources (

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