Why Emerging Biotech Companies are Increasingly Turning to Specialized Data CROs

In the fast-paced world of drug development, where breakthroughs can hinge on meticulous data collection, analysis, and stringent regulatory requirements, biotech companies are increasingly leveraging the expertise of Data Contract Research Organizations (CROs) like MMS.

These specialized firms offer a range of services that streamline and enhance the process of conducting research and clinical trials, making them invaluable partners to biotech innovators.

Here are the top reasons why companies are increasingly partnering with Data CROs for their studies, as follows.

Specialized Expertise

Many emerging biotech companies lack the in-house capabilities required for comprehensive data management and analysis. Data CROs bring a wealth of specialized expertise in areas such as biostatistics and regulatory compliance.

Over the past decade, the proportion of data collected in trials has shifted away from Electronic Data Capture (EDC), and simultaneously the complexity of protocol designs has increased, driving massive increases in data volume and complexity. Data deficiencies, either via poor data design, or execution, are among the largest drivers of failure for R&D assets.

Data CRO’s teams are well-versed in the intricacies of handling complex trial designs and clinical data, ensuring that studies are conducted with the highest standards of accuracy and reliability.

Efficiency and Speed

Time-to-market is critical in drug development. Data CROs are equipped with advanced technologies and methodologies that enable faster data collection, analysis, and reporting.

By leveraging their efficient processes, companies can accelerate study timelines whilst also enhancing quality. This agility is particularly crucial in the race to develop and commercialize new therapies and treatments.

Cost-Effectiveness

Outsourcing data management and analysis to CROs can be a cost-effective strategy for companies. Data CROs are inherently efficient given our focus on process optimization and risk mitigation.  

Outsourcing services to a Data CRO brings additional value by allowing companies to centralize the collection and analysis of their clinical data across multiple studies at a data-focused CRO that can support them from early clinical development through marketing approval. This allows emerging biotech companies that ability to select best-fit clinical vendors, depending on your study indication, phase, and regional/country level site needs, to support your clinical site activities.

Regulatory Compliance

Navigating regulatory requirements is a significant challenge in research and development. Data CROs like MMS, with our integrated Regulatory and Data specialists, have a deep understanding of the end-game use of the data produced during the development program.

We understand what Agencies will be focused on, the critical success factors around providing evidence of compliance, and in-depth expertise in the real-life application of regulatory guidelines and standards. This expertise maximizes the probability of a successful strategy, minimizes the risk of compliance issues, facilitating smoother interactions with Agencies and expediting the approval process.

Risk Mitigation

R&D is full of risks. Historically the data collected on trials was relatively simple, and almost all data sat in the clinical database. This has changed; protocols and endpoints are more complex, with dramatically more components.

More than 50 percent of data is also now collected outside the clinical database through third-party systems, and even from the patient themselves.

Data risks are now the most important sources of failure of the development of an asset, risking a potentially efficacious medicine never reaching the market.  Data CROs are much more adept at avoiding data risks at the design stage, or, if the risks need to be taken, ensuring there is adequate mitigation and surveillance. Data CROs also provide more rigorous data quality control and validation.

Their independent oversight and objective analysis reduce the likelihood of issues or errors, thereby enhancing the probability of successful study completion.

Scalability and Flexibility

The dynamic nature of clinical research demands scalability and flexibility in study design and execution. Data CROs offer customizable solutions that cater to varying project complexities and resource requirements.

Whether conducting small-scale early-stage proof-of-concept studies or large-scale multinational trials, organizations rely on Data CROs to adapt and respond swiftly to evolving research needs. Partnering with a central data specialist frees Sponsors to partner with the optimal specialty monitoring CRO by indication, or geography, and still have data support remain consistent across the program and over time.  

Not only does this retain knowledge of the data, but it also ensures an organized data room to help with later phase out-licensing, partnerships, or acquisition. It also set the stage for subsequent successful marketing applications.

Continuity

Unlike Clinical CROs where the focus is generally on the conduct of a specific clinical trial, Data CROs allow companies to form partnerships with the overall development plan in mind. 

Examples include pharmacovigilance teams that manage structured benefit-risk across multiple potential indications, regulatory affairs members that manage all submissions for a program, or a compliance team that implements consistent SOPs and process for all projects conducted by a sponsor. 

In each of these cases, small, core teams with experience in when and how to scale, can build and maintain institutional knowledge while ensuring efficiency and effectiveness.   

Integration With Clinical Teams

One of the most important aspects of study delivery success is how well different components of study teams interact. Traditionally, silos exist between the Study Site, the medical clinical and data teams.

This is true even when using a full-service CRO where limited focus gets put onto integration and collaboration.

Data CROs are laser-focused on optimizing key study relationships – particularly the trifecta of Site (PI and Study Coordinator)-CRA-Data Manager. The Data CRO has the clearest view on the overall status of the project and the individual site, allowing us to ensure transparency, flag risks, and prioritize efforts.

Technological Innovation

Staying at the forefront of technological advancements is crucial for acceleration of regulatory approvals. Data CROs invest heavily in cutting-edge technologies and analytical tools that empower biotech companies to harness big data, insights, and predictive modeling in real time throughout the study.

By leveraging these innovations, companies can uncover valuable insights and optimize development strategies more effectively.

Strength of Process for Marketing Applications

Ideally, the advantages listed above will all converge at the marketing application (MA) stage with the Data CRO accelerating timelines through strong and adaptive processes focused on critical path objectives.

A specialized, and efficient biostatistics team will pay off in smoother data integration and faster top-line delivery while conserving resources. The continuity established through strong regulatory compliance and risk-mitigation processes will culminate in a consistent, high-quality submission as well as effective preparation for FDA information requests and audits.

Critically, scalability is significantly improved by the pre-existing relationship between sponsor and data CRO as the ability to rapidly onboard additional qualified team members depend on the presence of colleagues experienced with the sponsor project and processes.  

Conclusion

As biotech companies navigate the complexities of bringing new therapies to market, a partnership with a Data CRO can create a strategic alliance aimed at advancing R&D success and improving patient outcomes. By outsourcing data management and analysis to specialized CROs, biotech can enhance efficiency, mitigate risks, and accelerate the pace of innovation.

As the pharmaceutical R&D landscape continues to evolve, the role of Data CROs will remain pivotal in shaping the future of healthcare and biopharmaceutical research.

For questions on this article, email info@mmsholdings.com.

This article was written by Ben Dudley, Chief Commercial Officer and Mark Bernath, Director, Business Development.