How to choose a CRO

To whom would you trust your project from the wide variety of contract laboratories, all more than happy to offer you their services?

There are number of issues and aspects to consider when choosing the partner for your studies, their individual importance varying depending on the type of the study and the collaboration. In a long run, the best results are surely obtained from a collaboration that is a win-win situation for the both parties, and is built on a mutual respect, trust, transparency and flexibility from the both sides.



Ease of communication


This is where all starts from; how easily you can contact your partner, and get a meaningful response when most needed.


Go for a company with which you feel easy to communicate with, so that you know you can share your thoughts and ask anything, any time, and they are ready to help you. You may not feel this as a most important issue in the first place, but when things turn hectic and time is money, this is what you need. Some companies prefer e-mails in communication over telephone, which is nice because that way everything remains in records without extra notes and in scientific issues the answering is often easier when there is a minute to gather your thoughts. But you should also always feel comfortable to call your CRO, feeling rather welcomed than like disturbing their precious time. This is often also an issue where personal chemistries meet and make the most crucial impact.


The ease of communication also comes from clarity and professionalism; the best partner is transparent and does not try (or fail) to hide their message beyond unnecessary marketing talk or non-relevant details.



Scientific competence


In many Pharma companies the most important thing when choosing a CRO. Your partners need to be able to say they know and they can. Contract laboratory’s services have to be based on solid high-level scientific competence, so that you can feel secured on every detail they hand to you; starting from study planning and protocols, and proceeding similarly through practices applied in laboratory, high level interpretation of data and results, and fluid reporting with right matters in right place, not forgetting conclusions.


CRO have to be able to recommend you a certain study after hearing your specific needs, and equally importantly, scientifically argue why you need that particular study and not something else. Ask them regarding their recommendations, study approaches and practices, and all issues relevant the study, so you will get an impression about their expertise.


Nowadays many contract laboratories carry on lots of non-commercial scientific research on their own or/and as a collaboration with other companies or Universities, and publish the results in a form of scientific articles or conference talks and posters.Take a look to their web-site or marketing material, that material is surely used to tell you about their extraordinary expertise and publications. Remember however to confirm if the staff behind the published papers is still in the company or has the promoted expertise already walked out; there is at least one example of European “consolidated CRO” that is advertising with a long list of papers written by their ex-personnel (and even with papers that has nothing to do with the company). That kind of scientific research is a good sign of know-how, pointing to CRO’s growing interest towards higher understanding and search for new high-quality services for their customers. Not to mention that they love to use it as a marketing tool…





If CRO’s fixed service package is not exactly the right one for you, do they tailor it for you? Can they change the experimental parameters, such as number or length of time points, concentration levels, cofactors or analytical approach? Can they adopt your own study set up and report template?


Tailoring and modifying the experiments for each specific need and situation is also a sign of excellence as well, as breaking the normal rules - to do the task in a new way - needs higher understanding of the test system. The concept of flexibility comes up also in a number of other issues, such as pricing/invoicing system, and best of all, usually shortens the turn-around times. By choosing partner able to react rapidly to changes in experimental environment and your needs, you will save your time, money and nerves. Improved flexibility is often (but not always!) a strength of smaller companies that are not so much restricted by heavier bureaucracy or too strict quality systems, which is not to say that larger companies could not be flexible as well, or that quality systems would necessarily limit flexibility. In the end, and more than anything, flexibility is a general way of doing and matter of culture in the company, and something you absolutely want to have from your partner.



Broadness of service portfolio and special expertise


When you are outsourcing more than one type of studies, it is naturally a positive sign if you can get as many of those, at least the most closely related studies, from a one and the same partner. This usually saves time and money, as more experiments can be conducted from the same samples or same amount of compound, with lots of benefits in time consumption.


The laboratory that has studied your compound once has experience if there are certain precautions or problems in its handling, and they probably have ready analytical methods for the next studies – raising the quality and fastening the turnaround times. Even if you have only one study type to outsource at the moment, take a look to CRO’s portfolio, to see if can they offer you also other related services than the one at the moment, because most probably in the future you will need also some other studies in the field. At least hopefully you do, because it means that your project is going further in the pipeline!


It is however worth remembering that different companies have different principles in their service offering; others may have really strong focus and high expertise to certain area within which they prefer to stay, whereas others are offering very broad selection of studies but no extra key area of expertise. Similarly, others may prefer to work with slower but more optimized methods, whereas others go for less optimized high throughput. Therefore it may be worth to spend a moment by thinking if you need the highest quality, broadest portfolio, or fastest turnaround time – all this rarely comes in the same package.



Pricing system


Is pricing system clear, so that you can easily see pricing for certain study, even if not asking for a quote? When to pay and how much?


If conducting certain studies for a regular basis, ask for a tailored long-term pricing system (quote) for the studies you are outsourcing. Many CROs are willing to give you cheaper prices if you buy more, both on a year-level (as a function of cumulative value of orders) and in each individual study, the latter because many study types contain lots of synergies in consumption of time or reagents if the study size is increased (e.g. by increasing number of compounds or species within the same study type).


Regarding invoicing, also ask for a way suitable for your company; smaller studies may be easier to pay/charge in one invoice only, whereas larger studies are usually paid in several steps (e.g. after signing contract/after preliminary results/after final report). And it should go without saying that compares the prices between CROs not only as numbers on the invoice, but with respect to the quality of the service. Aim rather for good price per quality ratio, than for low price only, as in your business the right results and all extra help are more valuable than anything.



Reporting and level of conclusions


The way how CRO builds up their report tells a lot also about their other actions. Some of them give you just results as numbers without reasons what was done and how they justify them to be correct; whereas others build up their reports in a closely manner to scientific papers, including intro, experimental, results & discussion, even conclusions and references. No matter how well the study has been conducted, it still can be ruined with a poor or unclear reporting. Ask for a model report specially to certain study types you need to outsource, see how clearly and exactly the report states what was the aim, what was done, how did the results look like, and what where the conclusions.


Did you understand what the report told you, and were all you need included, or did it raise more questions than answered? Good reporting and scientific competence goes hand in hand with the way your partner delivers the results; can they tell you what the numbers behind the results mean, and what to do next? Most importantly, ask the CRO to modify the report to your exact needs, so that the same template can be used fluently in the upcoming studies. Remember, reading of reports should not be a painful task and struggling to understand what is written, but an easy and smooth experience where you can simply focus to the main issue without extra disturbing questions in your mind due to unclear presentation. After all this, it is worth noticing that sometimes you may not need actual report at all, but only numbers and tables e.g. in an excel-file may be well enough – but that should be up to you, not the CRO.



Quality system


In discovery phase and early phase of development, quality system status is not needed from regulatory point of view, but in some studies during the later development and clinical studies the GLP status is required by the authorities.


Even if you work in a QC label free environment and do not need a label from quality system to your studies from official reasons, it is worth checking how your partner has taken care of the issue. The certified quality system is a sign that the company wants to show you they have paid attention to quality issues and work according to good practices, even not having a GLP but some other certificate. It however tells nothing about expertise, nor that is the scientific quality of their studies high – that expertise comes from the staff quality and not really from a certificate. However, this neither means that quality system is not needed, and it is worth checking that the laboratory works at least in a quality-system-like environment. This does not necessarily need to be certified, but meaning that they have standard operation procedures (SOPs) defining the basis and guidelines for all routine work, controlling the storage and handling of samples and compounds, adequate and safe & confidential data storage, and guaranteeing traceability of all experiments and other actions related to outsourced work.



Personnel qualification


Who are the persons you trust your samples, studies and perhaps the whole fate of the development project?


To start with, the first thing is that the people with right education, training and experience are in the right places. Regarding directing staff, the appropriate academic rank, background from a acknowledged party or proven scientific resume are positive signs, and if you want to be comprehensive, you may ask how the work is divided between the operational staff; are chemists, biochemists, or other scientists in a lab together with technicians and assistants, and who takes care of what in each phase of the study.





As well as it is important that the staff is well trained and knows what they are doing, it is worth checking that they have right tools for the job. This may be an overkill with respect to basic laboratory devices and tools, but with respect to high price equipment and gadgets, such as analytical instruments or robotics, it may be worth checking that the partner have the right and adequate instruments to produce high quality data.



Audit the laboratory


Even though discussions over phone and e-mails are convenient way to get an impression about your CRO, there is no other as good way to get the final opinion about the laboratory, facilities and staff than to see yourself. Visiting your partner and seeing the people face to face is always worth it, even though it may take couple of days and airports. You will get a much better and more personal relationship with the people, surely helping in take care the business, and you see the places, instruments and how things are done. And probably you have nothing against a nice dinner in a restaurant serving local specialties… The first step in meeting the CRO people, even from many companies at the same time, may be also easily established in exhibitions and conferences.





With respect to deeper personal relationship, and possibility to face-to-face meeting, the nearer the better. With respect to shipment issues and turnaround times - no matter at all. Logistics for all study related material works how it should work in the third millennium; you rarely see the difference if you send your material or samples 100 or 3000 miles. All taken care within the time range during which dry ice keeps your samples just perfect.



Ask your peers & colleagues


Perhaps one of the best ways to find a good contract laboratory. Ask your colleagues from the same field, which company they were satisfied with, who they would recommend. If being asked yourself, say your opinion frankly and give the feedback even to CROs, the general level by all CROs is increased if only the best get the contracts.



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