Outsourcing Clinical Trials: Key Considerations for Sponsors
Outsourcing is common practice in clinical trials; as the global clinical research market becomes ever more competitive, small to mid-size pharmaceutical and biotech companies must rely on the expertise, services and facilities of specialist clinical research organisations (CROs) and functional service providers (FSPs) to support their clinical development programs.
By partnering with outside expertise, smaller organisations can overcome major operational challenges and ensure a successful study delivery, helping them to compete with their bigger and better-resourced competitors.
In this article, we explore the key considerations for sponsors when outsourcing clinical trials, as well as market trends, and types of outsourcing.
An overview of the market
According to Precedence Research, in 2021, the clinical research outsourcing market was accounted at $41.5 billion. By 2022, this rose to $43.93 billion, and is expected to reach $69.2 billion by 2030. The contract research outsourcing market size is forecasted to increase at a compound annual growth rate (CAGR) of 5.85% by 2030 (2022 to 2030).
These figures highlight how the increased competition in conducting clinical research has led to a stronger reliance on outsourcing, due to the need for both better operational efficiency and therapeutic expertise.
Why are clinical trials outsourced?
Competition amongst pharmaceutical and biotech organisations has increased dramatically over recent years, with the rewards for being first in the race to market, or identifying the next blockbuster drug being higher than ever. In addition, medical advancements have increased the complexity and scale of clinical studies.
This greater competition has surged the demand for cost-efficient trials, and greater study complexity has increased the need for therapeutic and trial management expertise in specific study areas.
For sponsors without the necessary in-house capacity or expertise to meet these needs, the answer is often to outsource clinical trials, partnering with organisations who can help meet these requirements.
For instance, sponsors may manage study costs by outsourcing the clinical trial management to a contract research organisation (CRO). A full-service CRO partner will have more in-house experience across a wider range of clinical trials and will therefore be better positioned to work with the unique challenges of the study. They will also have moreexpertise in site management and risk reduction, which brings more potential for efficiencies in costs and timeline – .
Many CROs are also better positioned to assist with specialist therapeutic expertise, as they have more experience in running trials a particular disease area or indication. Sponsors often partner with organisations with suitable expertise in a therapeutic, particularly for studies that may be more challenging. For instance, Simbec-Orion offers therapeutic rare disease or oncology CRO services.
Types of clinical trial outsourcing
CROs work with various outsourcing models to meet the needs of the study. Some studies might only require a selection of key capabilities, while others require full-service outsourcing.
In either case, outsourcing models can be used to improve operational efficiencies and growth for sponsor companies, as well as improve the cost and time efficiency of drug development.
1. Functional service provider (FSP)
Functional service providers offer a singular or small collection of clinical functions to support the study. For example, the CRO might assist with clinical data management or central laboratory services
With FSPs, the CRO will provide the necessary staff and facilities to carry out specific tasks on a contract basis. The personnel work under the procedures outlined by the sponsor. This can be a useful model for small to mid-size biotechs and pharmaceutical companies, as it offers access to expert services on an ad hoc basis and removes the requirement to recruit for these specific roles in-house.
2. Full-service outsourcing (FSOs)
FSO involves outsourcing all, or the majority, of clinical development tasks to the CRO. With full-service outsourcing, the CRO takes on the full trial management and delivery process, which can be really helpful for sponsors without the capacity, facilities, or expertise to carry out the project.
Handing over the entire project to a single provider has the advantage of reducing the managment burden of the sponsor organisation.
3. Hybrid model
Hybrid models combine elements of both FSP and FSO. More complex trials can benefit from this more flexible approach which can cater to the specific needs of the trial elements and adapt where necessary.
A clinical trial may use a combination of FSO and FSP outsourcing models based on location and logistics or use a mixture of FSO and FSP models across study phases.
Considerations when outsourcing clinical trials
Clinical trial outsourcing is intended to improve the efficiency of research. By outsourcing, CROs handle the full clinical trial project management process.
In order to maximise this success, it’s important for sponsors to consider what they want, need and expect from outsourcing the study, and furthermore, what kind of CRO is most suitable for the project.
Some useful considerations to make when outsourcing clinical trials inlcude:
- Capacity and internal resources: The model of outsourcing you use will depend on the level of in-house knowledge, expertise and capacity of your internal team. For companies with fewer internal resources, it might make sense to go with a full-service outsource approach. Alternatively, , a company with a high level of expertise, staffing and resources might choose to outsource certain parts of the study using an FSP or hybrid model. In either case, it is a judgement for you as the sponsor to make, which will often depend on the needs of the study, and how well these needs are aligned with your current internal resources.
- Case studies and publications: When choosing which CRO to partner with for your outsourcing needs, it can be helpful to understand more about the organisation through case studies and publications. This will also help provide insights into their therapeutic areas and clinical specialisms.
- Project-specific expertise: As mentioned previoulsy, a common reason for outsourcing is access to project-specific expertise that your organisation’s internal team cannot provide. In the competitive environment of the pharmaceutical industry it is essential to ensure the study design is tailored to its specific function, by those with expertise in the study area, to improve the chances of study success..
This can help deliver study outcomes much faster and more efficiently, as well as reduce costs by only including the elements of the study that are necessary to acheive the endpoints identified.
A good CRO will be flexible in its operational approach, tailoring the trial to its specific needs and challenges.
How outsourcing can help drive success
Outsourcing clinical research services can help to ensure study success by providing experienced and qualified staff to manage all aspects of the project, from start to finish. By working with an experienced CRO such as Simbec-Orion, sponsors can reduce the risk of study delays or missed milestones, and ensure that their project is completed on time and within budget.
Let’s take a closer look at how outsourcing helped drive study success for some of our clients.
1. Improved study efficiency
Providing therapeutic expertise in a highly competitive field of oncology, we conducted a dose escalation study to investigate the safety and tolerability of the study drug in patients with relapsed/refractory non-hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).
The results: our expertise in rare disease and oncology studies helped ensure the therapeutic principle was established swiftly, and the sponsor could communicate the results with scientific and business communities earlier than anticipated.
View full case study: Helping the sponsor achieve first-in-patient study success.
2. Better facility support
One key driver of outsourcing clinical trials is to utilise external study facilities. Simbec-Orion provided central laboratory support to deliver time-critical delivery of samples for a study investigating Niemann-Pick disease type C (NP-C).
The results: with the help of central laboratory support, the observational study was completed in just 10 months, and the sponsor was swiftly able to expand the phase II and III interventional study in the US and Europe.
View full case study: Surpassing timelines & rapid enrolment in an
3. Overcome key challenges
CROs are familiar with the challenges faced in clinical trial design. In a study for a biotech sponsor investigating idiopathic pulmonary fibrosis (IPF), it was integral to tailor the study design to the needs of rare disease research. IPF affects 13 to 20 in 100,000 people.
The results: using an umbrella study design, tailored recruitment techniques and patient engagement strategies, we helped ensure that the limited patient population did not slow down early recruitment, and worked to mitigate the risk of patient dropout throughout.
Considerations for successful collaboration
When outsourcing a clinical trial, it is important to maintain a successful collaboration in order to ensure the study runs smoothly. Here are a few tips for ensuring a good working relationship between sponsors and the clinical research organisation conducting the trial:
- Establish clear expectations early on: It is important to establish clear expectations early on in the collaboration so that everyone is on the same page. This includes specifying what each party is responsible for, as well as defining deadlines and communication protocols.
- Understand each other’s language: collaboration relies on trust and understanding. In order for sponsors and CROs to develop a good working relationship, it’s helpful to understand each other’s ‘language’, culture and processes. Introductory sessions can be really beneficial here, giving internal and external teams the opportunity to develop a positive working partnership.
- Implement a communication plan: CROs and sponsors must ensure that communication is maintained throughout the study. Firstly, both parties should define their communication expectations, and secondly, put a centralised communication plan in place in order to facilitate this. CROs and sponsors can improve communication methods through cloud-based data sharing and secure messaging platforms. Regular communication is key to a successful collaboration. Make sure to communicate not only about issues that need to be addressed, but also about progress made and any challenges that have been encountered.
- Develop risk assessment plans: risk assessment is essential in clinical research. Sponsors and CROs should work closely with one another to design risk reduction strategies and procedures. This should be an ongoing process, performing risk assessments on site to ensure proper data quality management and risk mitigation throughout.
- Be flexible: In any collaborative arrangement, it is important to be flexible in order to accommodate the needs of both parties. If something comes up that affects the timeline or scope of the trial, be willing to work together to find a solution.
- Respect each other’s expertise: Each party involved in a clinical trial has unique expertise and knowledge that should be respected. Working together as a team will allow everyone to benefit from these different perspectives.
- Stay organised: It may sound simple, but it’s essential that the study is organised. In order for everyone involved in a clinical trial to stay on track, it is important to maintain good organisation. This includes tracking all tasks and responsibilities, as well as maintaining up-to-date documentation.
In recent decades, outsourcing has become less of a ‘nice to have’ and more of a necessity in clinical research. This is mainly due to the heightened competition in conducting clinical trials, which has led to a greater reliance on operational efficiency and therapeutic expertise from contract research organisations.
Outsourcing offers lots of flexibility for sponsors, with options to both fully outsource or partially outsource elements of the trial.
Partner with a full-service CRO
With therapeutic expertise in rare disease and oncology clinical studies, we respond to the needs of the research with agile study designs. Speak to our experts to learn how we can help. Contact us to start a conversation or submit an RFI/RFP.