Following a message from Aicha, we decided to write about this theme, which we thought was interesting.

Here is the message of Aicha,

Hello Vanessa, let me ask you again hus enhance the clinical research in my hospital.

I really wanted to congratulate you, Aicha, for this question. You really want to be an actor with clinical research in your center and it’s all to your honor!

Now I will give you some ideas to make your clinical research department, a successful department!

The first question that could be asked is what would it be for a CSC to help attract promoters and CROs to his service? There are, in my opinion, two reasons:

• The value of his work because being part of an elitist clinical research service is valuable for the team but also for oneself.
• Securing your job. A service that receives a lot of clinical trial application and that does a lot of study to a continuous workflow, which keeps jobs and hiring.

No clinical studies, no CSS position. The CSC therefore has every reason in the world to attract the CROs and the labs!

What do labs and CROs want?

To be able to value your service in clinical research, you need to understand what the laboratories and the CROs want. You have to discover their needs and then create a service that meets their expectations.

The laboratories and the CROs all look for the same thing: Investigation centers that will include many patients, in record time, with quality data. Their goal is to be able, secondly, to ensure the profitability as quickly as possible the promising molecules whose development has cost very expensive in order to help, as quickly as possible, many patients to cure. It’s not rocket science!

How to provide them with a service that meets their expectations?

To give labs and CROs the service they expect, two issues must be answered: getting the population in record time and quality data.

The right population in record time

As a first step, it is necessary to be able to identify within the service what is the expertise of your investigators. Which pathologies in particular attract the most your service? For example, if your department is specialized in hematology, patients may come in larger numbers for multiple myeloma. Your center will probably be recognized in this expertise and it is clinical trials relating to this pathology that must be targeted as a priority.

Your center is necessarily recognized for certain pathologies in particular, your site will bring a greater population in the pathology of which you are expert.

In a second step, all possible methods must be identified to recruit patients faster within your department. You will find plenty of ideas in the Mosio eBook which we have participated in, you can also read the article on recruiting patients in clinical trials.

Quality data

The quality of the data depends on good general organization of the clinical research department, good interaction with the other departments of the hospital, quality and involved staff, low protocol deviations and a high quality system (ISO9001, if possible).

Organize well with clinical trial management software

In order to carry out the studies, you must have the right tools to automate your work and save time. Working on multiple Excel tables is not convenient. Many hospitals and clinics have already taken the plunge and equipped themselves with clinical trial management software to be more efficient.

Quality procedures in clinical research

Some successful centers in clinical research have already established their own procedures. Quality procedures are a guarantee of consistent repetitions of the work of your center. Procedures can be effective while limiting errors and violations to Good Clinical Practices. I recommend that you create some clinical research procedures for the various activities of the department. You can create at minima:

• Procedures for filling in the case report forms
• Procedures for inclusion, screening and follow-up of patients
• Procedures for the management and dispatch of samples

Good clinical practice is clear about it: when conducting clinical trials, it is necessary to work within the framework of an appropriate quality management system. The top is to have a quality certificate (e.g. ISO9001) but this is not mandatory.

You can go to the blog of the QSE manager, you will find examples of procedures ISO9001 type from which you can be inspired. This way, you will show CROs and labs that quality is really a priority for your department. Ok, let’s work!

Cross-functional management to interact with other departments

Cross-functional management consists, without hierarchical power, in asserting, collaborating and cooperating with the participants in the hospital participating in the study. Apply without moderation this management that will allow you to manage your projects in a fluid way! The quality of the work of the clinical research team will then be recognized by the labs and the CROs. To learn more, we recommend you the article that we had written about cross-functional management.

Colleagues involved in the refined profile

Depending on your position, you probably will not have a choice about hiring your colleagues. Your employees must be involved and motivated to provide quality data.

However, if you have the opportunity to participate in recruitment, here are some tips to recruit collaborators who will help your department become a benchmark.

The choice of your collaborators must go through 6 points:

• Study of the CV
• Study of the cover letter
• Physical interview
• Profession Test
• English test (if required)
• Personality test

Recruitment is not a safe science. However, suitable profiles can be chosen by checking these few points. A face-to-face interview is usually not enough, you have to profile the ideal colleague before you go looking for him.

A 1-hour profession test on the work of CSC with real-life scenario allows to check the skills that are on the CV. To do this, prepare fictitious study papers with subtleties that you may have encountered during your professional experience (consent of the patient, input, etc.)

A personality test for the finalist candidates makes it possible to assess whether the candidate’s values are in line with those of the team. You will find the details of the different tests by clicking on the following link: Personality test. Warning, many of these tests are not free and require the intervention of a psychologist.

Finally, after the selection, it is necessary to be able to keep the motivation of the team intact over the long term. This requires recognition of the members of the group.

How to communicate well outside: the « Clinical site branding »

What is branding? In the field of marketing, branding is the discipline of managing trademarks, and in particular the branding of companies that exploit brands. In the personal domain, it is the management of his image (Wikipedia definition).

Some will tell me, what does marketing do in clinical research?

The goal of the Branding is to create a link between your department and the laboratories/CROs. So, as soon as they have a new clinical research project corresponding to your area of expertise, their first reaction will be to contact you.

To do this, you must find out how you are different, and what your strengths are in order to promote you with the target laboratories and CROs.

You will choose the laboratories and CROs specialized in your area of expertise. You will have to disseminate information using pure marketing tools: blog and social networks, business cards… Yes! You have to be bold and original. You can also create, with the endorsement of your investigator, a LinkedIn profile for your department and communicate your successes.

If hospitals like the IGR or the APHP do it, why not you? Clinical research units such as the one in Périgueux have already taken the plunge and I congratulate them for this initiative Page of the clinical research unit of Périgueux on LinkedIn.

Prospecting, an essential step

In parallel to get known through the branding, it is necessary to prospect. I know CSCs who do it and a priori, it works. To do this, you prepare a list of CROs and target laboratories and you contact them. Your prospects will be:

• CROs with whom you have worked in the past but with whom you no longer work,
• The laboratories you worked with in the past but with whom you no longer work,
• CROs conducting clinical trials,
• Laboratories with ongoing clinical trials.

You can go to the ANSM website to find the different laboratories active in clinical research, click on the ANSM clinical trials directory. You can also visit clinicaltrials.gov and refine your search by filtering by pathology or by country. For CROs, you can visit the AFCRO website. I mentioned above to identify the specialty of your department, it is up to you to contact the laboratories and the CROs with which you will be able to value this area of competence.

In addition, you must attend or participate in meetings, symposia or seminars for institutional or industrial clinical research and make useful contacts. Be on the lookout for this type of event. Speak of your center to those you meet and your desire to practice more and more studies. The desire to be attractive to promoters and CROs and to show it is a good sign of motivation. You will get noticed for sure!

All this may seem long and complicated but just half a day per working week on these points to move slowly but surely on these goals! You will progress step by step to become a center that people do not forget. We have nothing without nothing!

To make a good impression

You have well prepared your center to be in the quality standards of laboratories and CROs and they have decided to select your center for a screening visit after your answers to the feasibility questionnaire have been conclusive.

The evaluation of your center by the laboratory or the CRO is carried out in 4 points:

• Technical facilities (Do you have the necessary equipment, refrigerator, freezer, follow-up of T ° C etc…)
• Human resources (Do you have the necessary staff, CSCs, investigators, nurses and trained to GCP)
• Motivation (Does the molecule motivate you enough to include?)
• Center recruitment capacity (Is your active list sufficient, how many patients have you already included in this type of study?)

You have to prove that your center is perfectly suited to their project. Talk to them about your work methods, show them your quality system to demonstrate your organizational abilities. Also prove to them that you have the adequate population to participate in their study by making extractions from your clinical study management software (e.g. How many patients have you included in similar studies?). You can send a copy of the CVs of the team members with their GCP certificate – Good Clinical Practice). You have to invite the labs and the CROs to visit the premises so they realize you have all the necessary equipment and that all the follow-ups are in place.

You are selected! Congratulations! It only remains for you to maintain a service that meets their expectations in order to become or remain one of the stars centers of the labs and CROs.

Hang in there and all the best!

Written by Vanessa Montanari