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How do you choose the right partner for your clinical project?

Identify and select potential CROs for your clinical investigation/study

To move forward in your product development, you must plan a clinical study/investigation. How do you choose the right partner to perform the study among the hundreds of CROs on the market?

The clinical study/investigation is a critical stage in your product development. The selected CRO who will support you throughout the clinical investigation/study will have a decisive impact on the outcome. The first step of the selection is to decide which potential partners will be asked to submit a proposal. Most often, this decision is based on recommendations obtained by your network but are you sure that its experience is based on the same needs as yours?

Your project is unique! Its dimension is linked to the specific characteristics of your product, your own organisation and your priorities. Thanks to its knowledge of the CRO market, based on its own database and experience, ALTHEKIA helps you to consult potential partners most compatible with your features and expectations. ALTHEKIA then works with you to define the precise specifications of your request.

If you start with an inaccurate CRO identification and vaguely defined specifications, you impose additional constraints on your journey of innovation. We are at your side to support you in this phase and put the odds on your side.

How do you secure the outsourced part of your clinical project ?

The right CRO for your clinical study/investigation

Funding a clinical project is a considerable investment for any company. Securing the outsourced part of the project is therefore essential and actually begins before the clinical investigation/study. 

Let’s be honest, in this field, you plan the initial study and then perform the actual study and, in most cases, they are not the same! Nevertheless, the difference between the two can be reduced if, at the outset, things are correctly defined in terms of study design, planned budget and schedule.

Once you have defined the main features of your study/investigation (objectives, type of investigation sites, etc.) and your in-house approach to the project (outsourcing strategy, internal allocated resources, etc.), you then need to define what you expect from CROs based on their own words to ensure that you outsource exactly what you need, the way you need. ALTHEKIA supports you in the development of these detailed specifications to share with consulted CROs in terms of assignments, detailed services, expected level of involvement, precise planning, etc. Then ALTHEKIA manages the call for tenders with the CROs and, thanks to its combined expertise in purchasing and clinical trials, ALTHEKIA ensures CRO proposals meet all your requirements.

For a given project, with the same shared specifications, you will never get the same proposal from one CRO to another. We are on hand to analyse them for you so that you can make the best decision.         

How do you control the budget of your clinical project ?

Managing the budget of your clinical investigation/study

The ideal clinical study/investigation does not necessarily coincide with financial reality. Even though your clinical project is just one part of your innovation’s journey, its cost represents a significant share of your R&D expenditure.

Congrats! You have already defined and sent a call for tenders to several CROs and you are eager to receive and compare their proposals. But when you take a closer look at the proposals received, you will see that making a comparison is not as easy as expected.

Each CRO sent you a financial proposal based on its understanding of your expectations. each bid received includes dozens of expenditure lines, several pages of detailed budget calculations but never with the same structure. How can you be sure that all expenditure items are included? How can you compare apples and oranges? ALTHEKIA provides the necessary tools to carry out this analysis. With a tailor-made call for tenders for your project including a customised cost breakdown, ALTHEKIA compares the proposals received and ensures provision has been made for all project expenses to avoid any unpleasant surprises later. Thanks to its combined expertise in purchasing an clinical trials, ALTHEKIA also negotiates the commercial terms of your collaboration with the CRO for the initial agreement and subsequent change orders where necessary.

Minimising budget variations is an important aspect and this function is part of our services prior and during the implementation of the project. So leave it to us to negotiate the financial part of your clinical study/investigation to guarantee your budget.

How do you manage your clinical project from another continent ?

Come to Europe for your clinical project

There are many reasons why you may be required to come to Europe for your product development. But how can you proactively manage the selection of your European partners in an unknown market from abroad?

Clinical operations are just one component of your clinical project. Coming to Europe will also have an impact on other aspects of the project (regulations, product management, analyses, etc.). Every aspect must be identified, planned and coordinated. What is the best strategy for setting up your clinical study in Europe? How are you going to select potential partners from hundreds of CROs? How can you manage calls for tenders sent to various potential partners taking into account business practices?

So it is not easy to navigate through a foreign landscape of CROs and to ensure the success of your study! Who are the potential partners that meet your expectations? How can local regulations influence the progress of your projects? From the very outset when considering implementing your study in Europe, ALTHEKIA is on hand to give you the keys to the European market and to support you during the various stages of the project. Acting as a local member of your team, ALTHEKIA manages your call for tenders directly with potential partners in order to obtain the exact services you need at the right cost.

Choosing and managing European partners from another continent can give rise to biases that are difficult to identify and solve when you are so far away. We can act as your local relay to oversee the proper execution of your study.