Pharmaceutical Drug Development Challenges

Challenges Facing CROs and CMOs for Pharmaceutical Drug Development

CRO holding pharmaceutical sampleContract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are specialized biotechnology companies that provide vital services with developing new medicines and drugs for life science companies. While CROs and CMOs cover different areas, both face similar challenges as the process of developing new drugs continues to evolve.

CROs provide a variety of services at different stages of the drug discovery lifecycle, from early-stage ideation through Phase 4 clinical trials. Over the years, many pharmaceutical corporations have found that using CROs saves money during drug discovery by lowering overhead costs. In addition to cost savings, CROs allow drug makers to research more candidates rather than rely on the success of only one potential candidate for a breakthrough discovery. In addition to pharmaceutical companies, CROs are utilized by many research institutions, universities, and government organizations. Over the past decade, the utilization of CROs has grown exponentially and as more corporations and nonprofit organizations rely on them, the need to evolve to meet the changing demands also grows. The CRO industry is incredibly competitive and the leading organizations are forced to differentiate themselves constantly in order to succeed.

CMOs provide similar services to those offered by CROs, such as formulation development and early-stage clinical trials, however, CMOs tend to focus on a specific technology or dosage form and offer end-to-end solutions for drug developers. Drug developers keep production costs low by taking advantage of the existing infrastructure offered by CMOs around the world. CMOs take advantage of different international laws and build facilities in locations with less-stringent regulations and lower tax laws, so they can then pass these savings on to customers.

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As CROs and CMOs continue to grow, pharmaceutical companies need to be increasingly diligent when selecting a potential partner. Pharmaceutical companies can lose the most if production at a CMO is halted because they cannot prove compliance or receive a 483 warning letter from the FDA. According to PharmSource, CMOs will spend, on average, 70% of their operating cash flow on new plants and equipment, leaving them vulnerable if production is stopped and they cannot fulfill their orders. When selecting a contracting partner, pharmaceutical and biotechnology companies cede control of many aspects of the project and must rely on the partner organization to deliver results according to project specifications, while also adhering to stringent industry regulations. Since the highest risk is assumed by the company hiring a CRO or CMO, it is critical to implement a wide array of risk-mitigation tactics, such as sharing relevant data regarding project timelines and the quality of the environment the work is performed in. CROs and CMOs are under immense pressure from competitors and customers to deliver a product at an affordable cost, and these pressures can result in an end-product of variable quality. As regulatory requirements, GxP compliance, and quality are becoming increasingly more complex, having access to relevant data provided by the CROs and CMOs is crucial to ensure a healthy, successful partnership that delivers a viable end product.


pharmaceutical developmentThe Importance of Maintaining Data Integrity, Compliance, and Product Quality

CROs and CMOs are chosen on a myriad of factors: cost-effectiveness, the rate of project completion, relevant experience, and access to specialized capabilities or researchers. However, one of the most important factors influencing a company’s decision when selecting an organization to partner with is based on reputation and recommendations from peers. The biotechnology and pharmaceutical industries are close-knit communities attending similar tradeshows, conferences, and events to stay informed on emerging trends. If a CRO or CMO fails to meet a project deadline, delivers a product with varying quality, or lacks proper documentation to validate their results, it can have far-reaching, negative effects on their organization’s reputation.

Organizations that can readily prove compliance with FDA, GxP, and many other regulations, will actively utilize a robust Quality Management System (QMS) to constantly maintain optimal equipment and environmental conditions. This enables differentiation within the industry and provides competitive advantages. Maintaining easily accessible and shareable digital records allows CRO and CMOs to prove both internal and external validation for quality and compliance, whether records or reporting is requested by a regulatory agency such as the FDA, or a customer interested in the quality of service. According to Pharma-IQ, A lack of quality, a high frequency of mistakes, or a breach of contract are the three most common reasons a company chooses to end their partnership with a CRO or CMO, but having proper documentation proves to existing and potential customers that every step is taken to improve product quality, reduce variability in results, and minimize mistakes. This is only accomplished by maintaining a state-of-the-art facility that leverages new technologies and advanced analytical methods.

Fostering a collaborative environment with a CRO or CMO, rather than having a “they work for us” mentality, results in higher quality end products, as well as long-term partnerships beneficial to both parties. By implementing electronic solutions, such as Laboratory Information Management Systems (LIMS) or Electronic Lab Notebooks (ELN), CROs and CMOs can capture and store relevant data that is easily accessible and readily shared. Organizations that provide records proving all laboratory facilities, and manufacturing or storage equipment, such as refrigerators, freezers, incubators, bioreactors, clean rooms, or vivariums are properly calibrated and functioning will give partners the peace of mind of knowing that their investments, research, and quality of the end product are protected and will not be put at risk in the event of an audit by the FDA or other regulatory bodies for poorly maintained equipment or environments.

Implementing digital solutions enables companies to maintain control over critical operations, ambient parameters, and vital equipment at any stage of the drug development lifecycle. Any CRO or CMO shifting towards digital solutions and creating a fully integrated, state-of-the-art facility needs to find solutions that are cloud-based and utilize open Application Program Interfaces (APIs). Storing data in the cloud minimizes the number of dedicated resources to an IT department and allows for data to be easily shared and accessed through a secure connection, keeping pertinent data secure at a fraction of the cost of maintaining servers on-site. With an increasing rate of adoption for Internet of Things (IoT) devices in life science industries, it is critical to select digital solutions that integrate seamlessly with other solutions, are 21 CFR Part 11 compliant, and hardware or Original Equipment Manufacturer (OEM) agnostic. Aggregating data from disparate systems and accessing it through a web-based dashboard provides a comprehensive overview of critical operations and enables organizations to reduce time spent gathering information, analyzing data outputs from myriad devices, and generating reports for internal or external validation, as well as quality and compliance.

Benefits of Implementing a 24/7, Autonomous Monitoring System

pharmaceutical researchEach organization faces many challenges when implementing new technologies, strategies, or initiatives. If an organization fails to gain user adoption or implement the new system effectively, valuable resources are wasted and employees become resistant to other digital initiatives that require large capital investments. Autonomous solutions implemented by a professional team ensure digital transformation runs smoothly and the system functions optimally, without requiring employees to learn new processes or drastically alter workflows.

XiltriX is an autonomous, cloud-based laboratory monitoring solution that keeps a pulse on laboratory, storage, and manufacturing operations by collecting real-time data from disparate devices, ambient parameters, and critical building systems, such as BMS, HVAC, or backup generators. Unlike other monitoring companies, XiltriX implements and maintains industrial-grade hardware, while providing a cloud-based, user-friendly software, with 24/7 monitoring as a service from the XiltriX Safety Net team, all for an affordable monthly subscription.

The XiltriX SafetyNet team provides added services such as predictive analytics, automated reporting, and third-party alarm response and escalation to protect your science in the event of any deviation or failure, even when nobody else is around. XiltriX is a powerful, cloud-based system that leverages existing equipment and infrastructure on a homogenous platform, viewable from any computer, tablet or mobile device, bringing everything together to prevent loss and streamline quality and regulatory reporting. XiltriX uses redundant architecture to easily grow with your organization and integrate with vital equipment and systems.

To learn more about how XiltriX can ensure your facility’s critical assets and equipment are protected 24/7/365, schedule a free lab consultation with one of our experts.

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