Article | October 7, 2022
The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials.
For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care.
Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS.
Key Steps for Selecting Right Biotech Clinical Trial Management System
Prioritize Study Needs
Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices.
Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task.
Select CTMS with Multiple Integrations
Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection.
Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes.
Ensure System Compliance and Security
Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties.
While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project.
Assess the Scalability
Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility.
As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure.
The Closing Thought
A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.
Article | September 22, 2022
The robust global channel of more than, 800 gene and cell curatives presently in trials will produce clinical readouts in 2022, revealing what lies ahead for advanced curatives. The impact will be felt in 2022, no matter how you slice it. Eventually, how well industry and non-supervisory bodies unite to produce new frameworks for advanced therapies will shape the year 2022 and further.
Pacific Northwest talent will continue to contribute to the advancement of gene and cell curatives in both the short and long term, thanks to its deep pool of ground-breaking scientific developers, entrepreneurial directorial leadership, largely skilled translational scientists, and endured bio manufacturing technicians.
We may see continued on-life science fund withdrawal from biotech in 2021, but this can be anticipated as a strong comeback in 2022 by biotech industry, backed by deep-pocketed life science investors who are committed to this sector. A similar investment, combined with pharma's cash-heavy coffers, can result in increased junction and acquisition activity, which will be a challenge for some but an occasion for others.
Over the last five years, investment interest in Seattle and the Pacific Northwest has grown exponentially, from Vancouver, British Columbia, to Oregon. The region's explosive portfolio of new biotech companies, innovated out of academic centres, demonstrates the region's growing recognition of scientific invention. This created a belief that continued, especially because Seattle's start-ups and biotech enterprises are delivering on their pledge of clinical and patient impact.
Talent and staffing will continue to be difficult to find. It's a CEO's market, but many of these funds' return, and are not rising in proportion to the exorbitant prices they're paying to enter deals. This schism has become particularly pronounced in 2021. Hence, everyone in biotech is concerned about reclamation and retention.
Article | July 11, 2022
If you have ever visited the testing laboratory of a large biotechnology company, you will be aware that managing the laboratory's operations single-handedly is no easy task. The greater the size of a lab, the more research and testing activities it must accommodate.
A variety of diagnostic tests are prescribed for patients in order to detect various diseases. For example, it may include blood glucose testing for diabetics, lipid panel, or liver panel tests for evaluating cardiac risk and liver function, cultures for diagnosing infections, thyroid function tests, and others.
Laboratory management solutions such as laboratory information management systems (LIMS) and other software play a significant role in managing various operational data at biotech laboratories. It is one of the important types of software developed to address thedata management and regulatory challenges of laboratories. The software enhances the operational efficiency of biotech labs by streamlining workflows, proper record-keeping, and eradicating the need for manually maintaining data.
What Are the Benefits of Laboratory Information Management Software in Biotechnology?
As the trends of digitization and technology continue to create deeper inroads into the biotechnology sector, a significant rise in the adoption of innovative medical software solutions, such as LIMS, is being witnessed for managing research data, testing reports, and post-research results globally. Here are a few reasons that are encouraging biotech facilities to adopt LIMS solutions
Real-Time Data Collection and Tracking
Previously, collecting and transporting samples was a tedious and time-consuming task. However, the adoption of LIMS with innovative tracking modules has made the job easier. The real-time sample tracking feature of LIMS has made it possible for personnel to collect the research data in real-time and manage and control the workflow with a few mouse clicks on the screen.
LIMS makes it possible to test workflows while giving users complete control over the testing process. A laboratory is able to collect data, schedule equipment maintenance or upgrades, enhance operational efficiency, and maintain a lower overhead with the help of the LIMS, thereby increasing revenue.
With its completion monitoring, LIMS speeds up laboratory workflows and keeps track of information. It assigns tasks to the specialist along with keeping a real-time track of the status and completion of each task. LIMS is integrated into the laboratory using lab information, which ultimately speeds up internal processes and streamlines the workflow.
Automatic Data Exchange
LIMS solutions store data in a centralized database. Automated transfer of data between departments and organizations is one of the major features of LIMS. Through its automated information exchange feature, LIMS improves internal operations, decreases the reporting time for data sharing, and assists in faster decision-making.
As the healthcare sector continues to ride the wave of digital transformation, biotech laboratories are emphasizing adopting newer technologies to keep up with the changes.
Citing this trend, laboratory information management systems are becoming crucial for biotech and medical organizations for maintaining research data, instant reporting, and managing confidential, inventory, and financial data with centralized data storage.
Article | July 5, 2022
Genetic therapeutics such as genetic engineering and gene therapy are increasingly emerging as one of the most influential and transformed biotechnological solutions around the globe in recent times. These genetic solutions are being assessed across various medical domains, including cancer treatment, neurology, oncology, and ophthalmology. Citing the trend, the genetics industry is estimated to experience a tsunami of approvals, with over 1,000 cell and gene therapy clinical trials currently underway and over 900 companies worldwide focusing on these cutting-edge therapies.
Growing Cancer Encourages Advancements in Genetic Technologies
With the surging cases of cancers such as leukemias, carcinomas, lymphomas, and others, patients worldwide are increasing their spending on adopting novel therapeutic solutions for non-recurring treatment of the disease, such as gene therapy, genetic engineering, T-cell therapy, and gene editing.
As per a study by the Fight Cancer Organization, spending on the treatment of cancer increased to $200.7 billion, and the amount is anticipated to exceed $245 billion by the end of 2030.
Growing revenue prospects are encouraging biotechnology and biopharmaceutical companies to develop novel genetic solutions for cancer treatment. For instance, Bristol-Myers Squibb K.K., a Japanese pharmaceutical company, introduced a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, Abecma, for the treatment of relapsed or refractory (R/R) multiple myeloma in 2022.
Amid a New Market: Genetics Will Attract Massive Investments
Despite several developments and technological advancements, genetics is still considered to be in a nascent stage, providing significant prospects for growth to the companies that are already operating in the domain.
Genetics solutions such as gene therapies, gene editing, and T-cell immunotherapy are emerging as highly active treatments across various medical fields, resulting in increasing research and development activities across the domain, drawing significant attention from investors. Given the potential of genetic treatments and the focus on finding new ways to treat cancer and other related diseases, it's easy to understand why companies are investing in the domain.
For instance, Pfizer has recently announced an investment of around $800 million to construct development facilities supporting gene therapy manufacturing from initial preclinical research through final commercial-scale production.
Due to these advancements, cell and gene therapies are forecast to grow from $4 billion annually to more than $45 billion, exhibiting growth at a 63% CAGR.
The Future of Genetics
Though there is a significant rise in advancement in genetic technologies and developments, the number of approved genetic treatments remains extremely small. However, with gene transfer and CRISPR solutions emerging as new modalities for cancer treatment, the start-up companies will attract a growing amount and proportion of private and public investments.
This is expected present a tremendous opportunity for biopharma and biotechnology investors to help fund and benefit from the medical industry's shift from traditional treatments to cutting-edge genetic therapeutics in the coming years.