Choosing a CRO to work with is no small decision – not least because it could make or break your research project. Read on to discover how we work with clients to optimize results and why you should consider running your trials in Central and Eastern Europe (CEE).
THE PHARMNET APPROACH
WHAT DOES IT MEAN TO CONDUCT CLINICAL TRIALS IN CEE AND THE EU?
Marketing authorization in the EU provides access to:
- Economically, one of the strongest regions worldwide
- A population of 512 million people
- State-of-the-art healthcare which is easily accessible for the majority of the population
Central and Eastern Europe (CEE) is a dynamic region with approximately 1,000 new trials registered each year. In this region, healthcare is mostly centralized resulting in more patients in fewer locations, which aids patient recruitment. In general, patients trust their physicians, and physicians are keen to participate in clinical trials.
- DYNAMIC REGION
- CENTRALIZED HEALTHCARE SYSTEMS AID PATIENT RECRUITMENT
- WELL REGULATED
In 2022, EU legislation, ‘the Clinical Trials Regulation’, was introduced to ensure the EU offers an attractive and favorable environment for carrying out large-scale clinical research with high standards of transparency as well as safety for clinical trial participants. This regulation harmonizes the processes for assessment and supervision of clinical trials throughout the EU and enables sponsors to submit just one online application for approval instead of submitting to each country separately. Criteria for the European Medicine Agency (EMA) and FDA authorization are very similar.
WORKING WITH US
Commitment to our clients is always our highest priority and we value customer satisfaction as much as generating results.
CLARITY IS KEY FOR EFFICIENT, EFFECTIVE PROJECTS
Making things simple is our way to
Compliance
Transparency
Efficiency
Time adherence
Clear, open communication is key to good project management and excellent client relations. Providing fast performance feedback to our clients may sometimes bring good news or sometimes bad news, but we do not come with surprises.
HOW WILL PHARMNET PLAN YOUR PROJECT?
Our established process provides clarity and efficiency, so everyone knows what comes next. The following shows what this looks like in practice.
1
Detailed discussion with the client about the pros and cons of the project – Let’s define the project idea
2
Preparation of the study’s preliminary outline – Let’s put the defined idea on paper
3
Further client discussion – Let’s confirm that we’re going to achieve our goals from a clinical perspective
4
Study endpoints discussion and selection of the primary one – Let’s ask our statisticians to provide preliminary estimations of sample size for various scenarios (taking the time needed)
5
Navigation through the regulatory waters and verification of the study design – Let’s ensure we have the most efficient design with no doubt of acceptance by the regulatory body
YES,
WE HAVE THE PLAN FOR YOU!
Now we translate the agreed plan into timescales and finances – Let’s do the top-line feasibility to offer various scenarios in terms of time and costs!
ASSESSING THE TOP-LINE FEASIBILITY
In our experience, generating a top-line feasibility is one of the best investments you can make. Whether the news is good or bad, this important early stage will help prevent future surprises.
We use established processes and contacts to manage the top-line feasibility quickly and reliably, leaving you free to focus on other tasks. The results of this feasibility study enable a go/no-go decision to be made with confidence.
INPUTS
- Pharmnet’s own experience
- Feedback from key opinion leaders
- Additional details from our network of potential sites
- Therapeutic area executive summary (country-specific)
REVIEW - DO WE HAVE ENOUGH INFORMATION?
Is there sufficient data showing the reasonable time and costs for project execution?
Or shall we revisit the project definitions?
Different countries manage patients differently. Have we chosen ones that offer efficiency?