Effectively Choosing a CRO that Best Suits Your Needs
You only need to search on Google to find the endless list of global and local contract research service providers. The current Contract Research Organisation (CRO) landscape is vast, with offerings from functional to a full service CROs, such as Covance, Parexel and Quintiles. Using a CRO’s expertise can maximise the efficiency of your clinical trials, but only if you choose the right one for the project at hand.
The selection process
The first step is to establish your outsourcing strategy, begin with the end in mind. What are your aims? What are your company’s requirements for your trial? Once you identified your goals, you need to define the key competencies your provider will have to ensure you meet these.
The next stage of the selection process will involve making a long RFI list of suppliers, and creating a shortlist about 3-4 suppliers. However this is not an easy task: “Comparing CROs difficult and sometimes unfair. It all depends on what the client pharmaceutical company needs,” said David Holly, Director IVR/IWR Product Development at BioClinica in an interview with Pharma IQ.
Finding the right fit in terms of requirements and budget, entails a stringent auditing process and validation of the information available to you. The main aim of the outsourcing department or in a smaller client company, the clinical study manager, will be to minimise risk. “When you start collaboration, it is also good to exchange figures on financial status of both parties for the duration of the partnership” said Christian Hucke, Clinical Development Manager at Affimed Therapeutics, at IQPC's Global Clinical Outsourcing Forum in May. This is especially important between smaller sized CROs and client companies.
The size of both CRO and sponsor company is significant in the vendor selection process. There is a perception of greater safety and minimised risk with a larger CRO. However, there are also potential advantages to using a smaller CRO, such as reduced cost. “I think that smaller CROs are often more flexible” said Anne Maria Ylisaari, Head of In-and-Outsourcing, Global Clinical Alliances at Orion Pharma, whilst sharing her insights at IQPC's Global Clinical Outsourcing Forum this year.
The requirements of different sized sponsor companies also vary. Unlike big pharma, smaller biotechs working on niche products will have limited budgets that tend to be controlled by VCs. They may also not have certain departments in place, and therefore require a greater service offering from an external partner.
“There are many small to medium sized pharmaceutical companies that do not have their own IT groups. Some don't even have regulatory support. A lot of smaller companies don't have people dedicated to auditing vendors, making vendor selection more difficult. So, the needs of smaller pharmaceutical companies could likely include SAS programming, monitoring, site selection, and regulatory services from a full service CRO” Holly said to Pharma IQ.
Big pharma will also have greater experience of selecting and working with vendors and outsourcing partners, and will tend to choose to work with a CRO known for their expertise in a certain area. Holly continued:
“The large pharmaceutical companies - like the top 10 - usually don't need a lot of extra services since they have entire departments dedicated to SAS programming, regulatory affairs, monitoring, etc. So, the needs of larger pharmaceutical companies may be much narrower in scope. For example, they may go directly to an EDC provider, rather than acquire EDC through a full service CRO.”
Hucke also posed a provocative question at the IQPC fourm: “Is the level of attention you get directly proportional to the level of business volume you create?” Or in other words, should small companies do better when they do business with smaller companies?
All pharmaceutical companies want to ensure that they get the right level of attention from their CRO, after they have signed on the dotted line, but Hucke said at the conference: “There is a strong feeling among small bio and pharmaceutical companies, that it is not easy to get the right level of attention from big CROs. There is not always the feeling that you are a valuable customer.” CROs must take note as they cannot afford to underperform with smaller client, especially in the current economic climate. Reputation is crucial to maintaining and acquiring new business, and small pharma can shout just as loud as big pharma.
Hucke also made it clear to the audience, that the responsibility does not lie solely with the CRO. As a sponsor you need to make yourself attractive to the CRO: “In the end all business is people business, conflict is natural in a relationship it will happened all the time. A good relationship requires fairness from both sides. To actively manage a relationship, is one way to ensure the right level of attention from a project,” he said.
The contract is signed
After the contract is signed you will need to have an effective strategy in place for monitoring your CRO’s performance, and ensure that you have chosen right indicators to evaluate your relationship. Throughout the duration of the partnership you may require your CRO to be adaptable, but bear in mind additional costs may be incurred if you change your requirements or need additional support. Clear communication from the outset will set you on the path for success.