Contract Development and Maintenance of Pharmaceutical Industry Software

Current Trends in Pharmaceutical Industry Outsourcing

Collaboration with external parties and the use of external expertise (like software outsourcing) are deeply ingrained in the history of the pharmaceutical industry. As per The Wall Street Journal, 30% of the medicines developed by the top 10 pharmaceutical firms were discovered by researchers from other organizations. However, the industry is facing mounting market presures and turning to external vendors more and more for their services.

According to Nice Insight, there will be a substantial increase in spending on outsourced services by the pharmaceutical industry over the next five years. More and more pharmaceutical and biotechnology companies are turning to outsourcing; the percentage of those spending over US$50 million annually has tripled in recent years – increasing from 23% in 2020 to 71% in 2023.

The IMS Institute has cautioned the top seventeen pharmaceutical companies that they will need to decrease their yearly operating costs by US$36 billion from 2023 levels if they want to sustain their current rate of research and development as well as their operational margins.

The pharmaceutical industry is becoming more and more cognizant of the potential consequences if they do not increase their dependence on external services and adjust their business strategies to meet the demands of the constantly evolving market. By heeding this shift, they can guarantee their continued success and competitiveness.

For pharmaceutical companies, outsourcing has emerged as a popular strategy for fulfilling the requirements of the contemporary industry. As detailed below, there are several key benefits associated with this approach.

  • Firstly, outsourcing has the potential to decrease operating expenses by granting access to less expensive labour and resources. This can particularly benefit tasks that do not require significant expertise or investment, like data entry or product assembly. (Learn more)
  • Secondly, outsourcing allows companies to acquire novel skills and technologies that can be advantageous in specific areas. This encompasses the creation of new products or processes, or the implementation of more efficient modes of operation.
  • Ultimately, outsourcing grants companies the ability to dedicate more resources to their core business activities without compromising on peripheral tasks. This can pave the way for a more granular focus on endeavours that are expected to generate higher returns on investments.

To sum up, outsourcing bestows a variety of perks to pharmaceutical companies, ranging from cost savings to the acquisition of novel skills and technologies. It is, therefore, not unexpected that this approach is gaining more and more popularity.

The Advantages of Pharmaceutical Industry Contract Manufacturing

Heightened concern from both customers and lawmakers regarding rising medication prices has resulted in heightened scrutiny of the pharmaceutical industry. As a result, pharmaceutical firms are compelled to expedite their development of new medicines while simultaneously adhering to strict protocols and secure procedures. This has presented a distinct challenge as testing and clinical trial guidelines are frequently subject to change. Consequently, it is vital for the pharmaceutical industry to stay abreast of these fluctuating regulations to ensure continued effective and efficient treatments.

To fulfill customer demands, pharmaceutical companies are becoming progressively reliant on outsourcing for various activities, ranging from research to software development. While outsourcing is typically affiliated with cost savings, studies indicate that the chief incentive driving outsourcing in the pharmaceutical industry is improving quality (54%), with increased speed to market (49%) and cost reduction (45%) being secondary factors.

The research cited above illustrates that ensuring superior quality is the foremost concern of pharmaceutical companies when outsourcing, in addition to saving considerable time and money on drug development and production. This allows pharmaceutical businesses to focus more of their resources and efforts on marketing and sales. Thus, it is worth investigating the potential advantages of outsourcing for pharmaceutical enterprises.

Accelerated Time to Market

Currently, the pharmaceutical sector is undergoing a swift transformation owing to the growing importance of data. This has created a challenge for many pharmaceutical enterprises, as they must be agile and proficient in their business processes to retain their competitiveness in the digital era. Therefore, it is critical for companies in this field to adapt to the speedily evolving landscape.

Presently, pharmaceutical companies are embracing a more versatile approach to introducing their products to the market. To curtail the time taken for this process, many firms have partnered with outsourcing companies to amalgamate their internal and external resources.

Reductions in Costs

Pharmaceutical companies continue to experience difficulty retaining their profit margins due to the substantial expenses linked to sustaining in-house research teams and sophisticated infrastructure. According to the Tufts Center for the Study of Drug Development, taking a new medicine from discovery to pharmacy shelves can cost a staggering US$2.7 billion. This expense is presenting a significant obstacle for pharmaceutical enterprises.

Drug manufacturers frequently outsource certain activities in an effort to minimise expenses. This strategy of consolidating the process can be more cost-effective and enhance their likelihood of success. By sidestepping the need to invest in pricey infrastructure or employ a large in-house research team to bring a novel medication to market, pharmaceutical companies may be able to reduce costs.

Access to State-of-the-Art Technology

The Human Genome Project’s conclusion has been immensely advantageous to the pharmaceutical industry, revealing an unparalleled volume of genetic data. Prior to this, only 500 gene-based pharmacological targets had been identified, but this figure has now skyrocketed to encompass over 120,000 genes and 10,000 potential therapeutic targets. Consequently, companies capable of leveraging this data to develop effective treatments are in great demand. Unfortunately, most pharmaceutical enterprises lack the internal expertise and technology necessary to fully capitalise on genomics’ potential.

It would be wise for the pharmaceutical sector to contemplate outsourcing their research and development to specialised university institutes or Contract Research Organisations (CROs) to gain access to the most advanced technology available. This move could potentially give them a competitive edge in crafting innovative products and services.

Risk Mitigation

Another vital factor that pharmaceutical companies must consider when evaluating the pros of outsourcing is the extensive regulatory framework that they must comply with. Even slight errors during the research, testing, or authorisation phases of medication manufacturing can have severe consequences for both the manufacturer and the patient.

The pharmaceutical industry is generating an immense volume of data, and the procedures for sanctioning new medications are becoming progressively intricate. As a result, an increasing number of companies are partnering with Clinical Research Organisations (CROs) that have considerable expertise in preparing documents that meet regulatory requirements.

Which Organization is in Charge of Drug Outsourcing?

Outsourcing can be a potent tool for pharmaceutical companies to attain their drug development objectives. Various types of service providers are typically involved in such collaborations, including but not limited to contract research organisations (CROs), clinical research organisations (CROs), contract manufacturing organisations (CMOs), technology service providers, and regulatory advisors. By collaborating closely with these partners, the pharmaceutical enterprise can utilise their expertise to expedite and streamline the drug discovery and development process.

  • Contract Research Organisations (CROs), organizations that conduct research as a contracted service

    Clinical Research Organisations (CROs) play a crucial role in the pharmaceutical, biotechnology, and medical device industries by undertaking various clinical studies. Furthermore, their services are also available to non-profit organisations as well as public and private educational institutions. When it comes to conducting clinical trials, specific CROs have the capability to coordinate the entire process from beginning to end, from finding appropriate study sites and recruiting participants to completing all the essential paperwork for approval from the Food and Drug Administration.
  • Organisations that undertake both the developer and manufacturer role on contract:

    Contract Development and Manufacturing Organisations (CDMOs) are entities that can aid in the final phases of pharmaceutical drug development. These stages may incorporate elements from preclinical trials, Phase I clinical trials, advanced phases of clinical trials, formal stability, scaling up, and commercial manufacturing. There are several advantages to collaborating with a CDMO, like adherence to regulatory requirements, production capacity, and efficient delivery.
  • In the domain of CSOs, or contract sales organisations:

    Certified Sales Organisations (CSOs) render ancillary services to those offered by the sales and marketing departments of pharmaceutical companies. These services can entail extra sales coverage customised to the specific requirements of a given territory or market segment, access to medical professionals who the company may not be able to contact directly, and various other benefits.

Over the last decade, there has been a significant surge in partnerships between pharmaceutical enterprises, Contract Research Organizations (CROs), and Contract Development and Manufacturing Organizations (CDMOs). This growth can mainly be attributed to the stricter regulations that the federal government has implemented to ensure the safety and efficacy of new medicines. With the pharmaceutical knowledge and technology base advancing rapidly, companies are embracing outsourcing as a means to retain their versatility and competitive advantage.

In recent times, several outsourcing firms in the pharmaceutical domain have undertaken measures to address the escalating need for IT support in utilising cutting-edge technologies. These technologies encompass high-throughput screens, analytical chemistry, data mining, and the identification of genes and proteins. Nowadays, an extensive range of services can be outsourced, from the initial laboratory work to the final stages of drug production and manufacturing.

The Pharmaceutical Industry’s Outsourced Tasks

Pharmaceutical enterprises usually employ a hybrid methodology towards outsourcing, wherein particular operations are outsourced externally, while others are managed in-house. This approach is frequently more economical and effective than adopting a uniform position regarding outsourcing.

Computerised Systems and Administrative Protocols

It is imperative to ensure that the processes involved in introducing a new medicine to the market are meticulously coordinated and managed by expert administrative personnel. Nonetheless, for pharmaceutical enterprises that provide a diverse range of prescription drugs, it is not unusual to discover that their administrative and supporting resources are under considerable strain.

Collaborating with external vendors who can provide scalable and efficient back-office support is a popular strategy for pharmaceutical businesses to supplement their in-house resources. For instance, emerging pharmaceutical companies may require more sophisticated business intelligence tools and analytics, as well as improved methods of data reporting and management to fortify their market position. By partnering with Works, you can eliminate the need to make hasty hiring decisions and the stress associated with hastily assembling an internal team.

Scientific and Engineering Disciplines

In the past, pharmaceutical companies have usually preferred to keep their research and development undertakings in-house, outsourcing only some activities such as clinical trials. However, the pharmaceutical industry is encountering mounting pressure to introduce innovative medicines to the public. Even with the extended and intricate medication approval procedures, investors anticipate pharmaceutical enterprises to deliver a significant number of new drugs every year. Furthermore, given the increasing accessibility of prospective targets manifesting genetic knowledge, there is a greater need for hastened drug development.

As a result, enterprises are more frequently considering outsourcing as a viable option from the initial phases of drug development. In numerous cases, firms select to collaborate with Contract Research Organizations (CROs) to conduct clinical trials, as they possess the requisite infrastructure and expertise to perform such assessments. Moreover, R&D services can be outsourced, allowing pharmaceutical companies to lower expenses and expedite the innovation of new medications.


Testing is a crucial challenge that necessitates attention during pharmaceutical production. Recent research has revealed that, by 2023, Contract Research Organizations (CROs) will be accountable for conducting a significant portion (72%) of all clinical trials, up from 23% in 2017. This is a substantial spike, and it is evident that CROs will persist in playing a critical role in the pharmaceutical development process.

Pharmaceutical enterprises may opt to carry out testing on their premises; however, this may entail a substantial investment of both time and capital. The requirement for in-depth documentation and the constant-evolving complexity of trial processes are contributing to the upsurge in outsourcing such tasks. Furthermore, the varying regulations across markets are also a significant factor in the growth of outsourcing in this industry. By availing the services of Contract Research Organizations (CROs), pharmaceutical companies can potentially reduce costs and time, whilst augmenting compliance with regulations and enhancing the quality of data assembled during trials, given the establishment of suitable collaborations.

The Future of Pharmaceutical Outsourcing

Progressions in genomics and other pioneering technologies are overhauling the manner in which pharmaceuticals are developed, driving substantial changes in the industry. For established enterprises to retain competitiveness and sustain relevance in the future, they must embrace data-driven processes and forge strategic partnerships. In the coming years, we can anticipate witnessing several advancements that will significantly impact the pharmaceutical sector.

Robotic Automation of Processes

Robotic Process Automation (RPA) is a rapidly expanding technology that businesses are utilizing to automate substantial quantities of repetitive tasks. This enables employees to allocate their time and efforts towards tasks of greater significance. The pharmaceutical industry is swiftly adopting this method to provide increased efficiency and productivity.

Contract Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs) can significantly profit from the adoption of Robotic Process Automation (RPA). By automating the gathering of data, such as results of clinical trials for novel pharmaceuticals and feedback from end users, researchers can save time and resources. The utilization of RPA streamlines the evaluation of test outcomes in real-time and facilitates efficient and auditable completion of repetitive tasks for pharmaceutical firms and their partners. Additionally, RPA contributes to quality data monitoring and regulatory compliance.

Introduction of Service Packages

As we progress into the future, we can anticipate observing a surge in pharmaceutical enterprises opting to package their services, rather than outsourcing them as separate components. This methodology presents numerous opportunities for enhanced collaboration between firms and their outsourcing partners, enabling companies to adopt a more comprehensive approach to their development. Furthermore, this approach can yield considerable cost reductions and process streamlining, whilst retaining the ability to efficiently replicate them.

Strategic Collaborations

The pharmaceutical industry is progressively shifting from one-time transactions to strategic, long-term collaborations. Through partnerships, pharmaceutical enterprises and universities, for instance, are closing the gap between academic and industrial research. Pharmaceutical firms can also leverage strategic collaborations with public or government-run bodies to access emerging markets. Another trend in the pharmaceutical sector is the delegation of IT and back-office services to offshore development organizations.

The Future Ahead: Automation

Companies that actively seek methods to automate their drug development processes will not only capitalize on the growing trend towards automation in the industry, but also gain a competitive advantage in the market. Pharmaceutical outsourcing does not present a one-size-fits-all solution; however, partnering with collaborators who can fulfil the technological demands of the modern pharmaceutical market is crucial.

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