Most of the small and mid-size pharma are stressed out while outsourcing pre-clinical and clinical development to CRO (Contract Research Organization). Selection factors differ while choosing CRO for large and small-medium scale companies. These include factors like budgeting, multiple region selection, and approaches.
Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of the clinical segment. The global CRO market was estimated at $31.6 billion in 2018 and was expected to reach $45.2 billion by 2022, according to a report.
Before going through the details, let’s first understand, what is a CRO (Contract Research Organizations)?
What is a CRO (Contract Research Organization)?
Contract research organizations (CRO) are the companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis.
What type of services does a CRO (Contract Research Organization) provide?
CRO provides services such as
- Biopharmaceutical development
- Biologic assay development
- Preclinical research
- Clinical research
- Clinical trials management and
Drug discovery is the largest segment by service type and accounts for approximately 33%, of the total CRO market.
The percent of CRO market in various regions is
- America: 45 to 50 percent,
- Europe: 35 to 40 percent,
- Asia: 12 to 15 percent, and
- Others: 4 to 5 percent
Most of the market revenue of more than 80% is from developed countries, such as the US, Canada, the EU, and Japan.
Now, the upcoming markets with great demand for regional CRO companies include China, Brazil, and Russia, which are strong in regulations and guidelines.
Sponsors are looking towards Asian countries like India as an emerging market due to cost-effective scenarios. This could be for services such as Biostatistics, Clinical Data Management, Pharmacovigilance, etc. This may further drive up the revenue of the Asia-Pacific region in the future.
Top 5 points to consider while choosing a CRO (Contract Research Organization)
- Quality of services
- Service cost
- Communication and relationship
What makes the difference between large and small-medium-scale pharma companies in choosing a CRO?
Here are some challenges for small, mid-size pharma companies before outsourcing to a CRO
- Big pharma companies can afford financially and often go with top CROs to minimize risks. But small & mid-size pharma companies need to go with multiple bids. This helps to choose the best CRO that fits into their budget and obtain quality services.
- Often best teams in CROs are engaged with big companies who commit to many clinical trials, and ‘B’ or ‘C’ teams are allocated to small companies.
- Assigning one project manager for multiple areas is observed and is often seen with small company sponsor projects to cut the expenses.
- Choosing top CRO results in high budgeting, but patient recruitment is a bit efficient due to their reputed name. Patients also prefer to participate in reputed organizations.
- Understanding the patient recruitment capabilities of smaller CROs is critical, as they require sufficient resources, strategies, and time in recruiting patients.
- Evaluating previous experience is also crucial before partnering, and particularly in rare disease clinical trials, where patient recruitment is often challenging. Many start-ups and small companies are working on rare disease drug developments, and choosing the best CRO for conducting clinical trials is challenging.
- Global reach is another crucial factor to consider. How many regions does the CRO handle? Small CROs often lack global reach and look to alliances with regional CROs. This may increase the overall cost involved and difficulty in project management.
Best practices in selecting a Contract Research Organization (CRO)?
For many small and medium pharmaceutical and biotech companies, outsourcing a project is not a preference, but a necessity. Conducting a clinical trial is a complex process, and selecting the right CRO is crucial for any sponsor, as this will drive the fate of the drug further.
There is no formula for outsourcing, but, there are several factors to consider before choosing a CRO. Let’s discuss some of the main points that we should look through.
Does the CRO provide the service you are looking for?
This question may look a little weird, but it is always important to clearly understand whether the CRO can provide the exact service you are looking for and how does it provide the service, whether it provides services through its employees or its subsidiary company or alliances.
Its always better to prefer that provides all the services under one umbrella as the project management and monitoring becomes easy.
If you are a smaller pharma company, It’s also important to know, how CRO looks at your project? whether it provides adequate priority, if no, then it’s good to go with a smaller CRO
What is the experience of a CRO?
It’s always important to evaluate the previous projects that are potentially similar to the proposed project and/or therapeutic area for an overview of the track record.
- CRO with no experience in the proposed project, may not be a good choice.
- Look for a research team composed of members with a wide range of expertise for the project. It’s advisable to conduct several meetings with the team members involving various expertise to gain knowledge on their capabilities and crisis handling skills.
- Evaluate the previously conducted projects thoroughly that are potentially similar to the proposed project and therapeutic area.
- Obtain a comprehensive overview of the CRO, such as organizational structure, accreditation status, facility and equipment, quality assurance procedures, and compliance with national and international guidelines.
- One of the crucial factors for CROs in conducting a clinical trial is recruiting a qualified investigator and site reach. The common mistakes made by most of the CROs are choosing the wrong investigator/site, which could be costly to the sponsor.
- The trial managers involved in the process of recruiting the clinical investigator must possess the skills and knowledge to know how and what to look to recruit a clinical investigator.
- The trial manager should also consider the number of patient visits and patient recruitment capability of that investigator, which is the determining factor for timely completion and obtain quality data for any clinical trial.
Status of the CRO
CROs operate with significant business risks, as the clinical trials may be stopped or canceled for ‘n’ number of reasons at any point in time. So choosing a CRO with sufficient bandwidth is very important.
Along with experience and potentiality, it’s also important to understand the CRO’s financial stability and capabilities to handle the downturns or crises and answers to questions like, Do they have sufficient infrastructure to handle and overcome the unexpected crisis? What strategies they would follow in extended timelines, poor patient recruitment scenarios, and adding more sites.
CRO service & delivery
Obtaining answers to the questions like,
- Do they maintain confidentiality and follow regular validations for data security, integrity, and management.
- Does the CRO integrate with your team to understand the project status and team follow-ups?
- How do they communicate and respond to your queries?.
- Does the CRO allow regular audits and inspection determined milestones.?
- How will they organize data and share it with you.?
- Do they utilize the latest trend and technology in various process of clinical research such as
- AI (Artificial Intelligence) & ML (Machine Learning)
- Novel trial designs
Would give an overview of how smoothly you would complete your project.
Prefer using a single contact person assigned to that project who will be looking into various strategies involved in the project, such as budgeting, scheduling, and managing the project.
Review the feedback
It’s important to get the client’s references and feedback before choosing a CRO. This may be a projection tool to understand the organization’s performance.
Getting as much feedback as possible before going with a CRO is always crucial as it may help to get confidence and strengthen the choice.
What is the cost of the service?
The service costs impact the total development cost of the drug but should be considered as a secondary criterion after primary factors, such as producing quality data, and timely completion of the project.
- For small and medium-sized companies, the cost will likely be a primary factor, and there is a tricky understanding between low and high-cost bids.
- Very low bids may indicate the inexperience of CRO in poor understanding of the project depth, and moving with very high-cost bids may not guarantee to obtain high-quality data or timely completion of the project.
- A well-balanced choice between quality and cost is tricky but important.
Conducting market research before going with any CRO is also an advisable approach to reduce failures or burdens. For example, understanding the regional regulatory overview, patient population, patient pool available for the clinical trials and regional regulatory support is important. This is more prominent in rare disease clinical trials as many trials fail in recruiting and retaining patients.
This sort of questions can be answered by conducting a regional-level & investigator/site level feasibility
Top CRO (Contract Research Organizations)
With expansions, consolidations, and innovations continuing throughout the CRO industry, here are the top 10 CROs in 2019 considering market share and revenue
Check out our article – Top 10 Contract Research Organizations For Your Clinical Trials: Top 10 (And More) – Part I which may help you more in choosing between the top CROs and small & mid-range CROs.
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