Biostatistics services help clinical trials ensure the scientific validity, reliability and accurate interpretation of data. However, a sponsor or contract research organization (CRO) may need to outsource these services on a project or study basis. Here are four reasons third-party biostatistics services are a good idea.
What Are Outsourced Biostatistics Services?
Outsourced biostatistics services involve hiring external specialized firms or experts, such as a CRO, to handle an organization’s statistical analysis and data interpretation needs. Due to their complexity and regulatory requirements, these services are particularly common in clinical trials.
Outsourced biostatistics services encompass a wide range of activities, including:
- The design of clinical trials.
- Sample size calculation.
- Data analysis.
- The analysis of clinical trial data to ensure regulatory compliance and support new drug applications.
A sponsor or CRO may need to outsource its biostatistics services to a CRO for a specific project or study. This can happen when its team is too small and inexperienced, or the project is too large for its internal group to handle, so it needs additional resources from a third party. Let’s explore the advantages of delegating these services to a third party.
4 Ways Outsourced Biostatistics Services Improve Clinical Trials
Outsourcing your biostatistics services for a clinical trial offers several benefits. Let’s examine each one in detail.
- Expertise
- Cost-effectiveness
- Scalability
- Avoid conflict of interest
1. Expertise
Outsourced biostatistics services bring specialized knowledge and experience to the table, ensuring high-quality analysis and adherence to project timelines. Experts in this field are well-versed in regulatory requirements and the latest methodologies, which help maintain data integrity and reliability.
Just as a professional builder can navigate construction challenges more effectively than an amateur, experienced CROs can anticipate and address potential issues in clinical trial data analysis. With experience working on many studies and with many sponsors, they can apply insights from past projects to benefit your study.
2. Cost-Effectiveness
In certain situations, outsourcing biostatistics services may be more cost-effective than maintaining an in-house team because you reduce overhead costs associated with hiring, training and retaining full-time staff.
Additionally, many CROs that offer biostatistics services operate in regions with lower labor costs, which can significantly reduce expenses. By leveraging these cost advantages, you can manage your budget more effectively and allocate resources to other critical areas.
3. Scalability
When you use the same CRO for multiple biostatistics projects, you can scale your operations accordingly. A consistent team ensures that accumulated knowledge and experience from previous projects can be applied to new studies, facilitating efficient scaling and consistent quality across trials.
If you ever need to scale down, the flexibility offered by outsourcing allows for easy adjustment of support levels without the complexities of managing full-time staff. Plus, having a standby resource ready to handle large-scale requests and provide immediate support during regulatory submissions enhances your confidence and preparedness, ensuring smooth and successful trial processes.
CROs are also more flexible in resource management. Depending on the sponsor or study needs, the team the CRO puts together can be customized to include specific expertise, skill sets, and the appropriate number of personnel. This ensures the right resources are allocated to meet the project’s requirements.
4. Avoid Conflict of Interest
Outsourcing biostatistics services helps maintain objectivity and impartiality in data analysis, reducing the risk of biased results that could arise from internal pressures or conflicts of interest. This independence is particularly important for Data and Safety Monitoring Boards (DSMBs) and Data Monitoring Committees (DMCs), which require unbiased statistical analysis to ensure the safety and integrity of clinical trials.
You can ensure adherence to industry best practices and impartial evaluation by outsourcing these unblinded services to specialized firms, like CROs. This approach maintains the integrity of the trial process and fosters trust in the findings, which is crucial for regulatory approval and scientific credibility.
How to Find the Right Biostats Partner
When you’re ready to begin the search for a CRO that provides outsourced biostatistics services, follow these key steps to achieve success:
- Identify your needs. Determine what kind of work you would outsource to a vendor. After talking to Biostatistical professionals, you may notice that what you think you need is different than what you actually need.
- Look for a biostatistics vendor. You can do this through referrals, attending conferences or doing a Google search.
- Identify a few interested partners. Schedule initial meetings with them to learn about their general capabilities. These first meetings are usually 30 minutes to 1 hour long. Ask each potential partner about their experience, expertise in disease areas, team structure, number of people on their team and outsourced model.
- Set up a confidentiality disclosure agreement (CDA) with interested partners. This allows you to talk more freely about your specific study needs. Involve subject matter experts with technical backgrounds so they can provide more feedback in real time.
- Initiate a formal step to request a proposal. Outline a Request for Proposal (RFP) where you list tasks you’re looking for vendors to complete and any other study specifics. Specify the biostatistical services needed, including technical requirements, defined expectations for deliverables, timelines and evaluation criteria. The RFP is often sent to a few CROs to bid on.
- Compare partner proposals. Consider budget, flexibility, expertise, relevant experience with the study, team size, communication, background experience and risk management plan to ensure alignment with your requirements.
- Invite interested partners for business defense. This formal meeting allows the CROs to present their proposals, and you get the opportunity to meet with the teams you would be working with.
- Make a decision. Choose the CRO that best fits your needs.
- Sign a contract. Congratulations, you have established a partnership for outsourced biostatistics services!
Conclusion
Outsourcing biostatistics services for your clinical trials can significantly enhance the quality and efficiency of your research endeavors. By partnering with a specialized CRO, you gain access to expertise, cost-effectiveness, scalability and the ability to avoid conflicts of interest, all of which are crucial for maintaining the integrity and success of your trials.
Firma is an experienced CRO dedicated to delivering innovative statistical consulting and advanced data analysis to sponsors and other CROs. When you need to outsource your biostatistics services, count on Firma for unmatched support. Please contact us to start the conversation.