Mediconomics – für individuelle CRO-Lösungen.

CRO for clinical studies in neurology

Our solutions for clinical studies in neurology

Neurological diseases have long been one of the greatest challenges in medicine. Even today, despite numerous innovations and innovative therapy methods, the treatment of neurological impairments is one of the most complex problems doctors are confronted with. Continuous improvement of these treatment options is therefore essential to support both patients and medical staff and make some of this challenge easier for them.

Since our company was founded over 25 years ago, we as a team have gained in-depth knowledge in conducting a wide range of clinical trials. Neurological studies have also been a challenge for us, but in the end we have always been able to master them successfully. We understand the complex requirements associated with neurological diseases and are ready to face these challenges together with you and lead your study to success.

Customized solutions

Neurological studies almost exclusively deal with very complex topics, which represent a heavy burden for the majority of those affected. It is therefore all the more important to make a contribution to research here. And optimal research requires a study protocol that is specifically tailored to it. We are aware that the success of a study depends to a large extent on the design of the protocol. For this reason, we offer you:

  • Individual study protocols: We create study protocols that are tailored to the various clinical pictures and treatment approaches. We will work closely with you to identify the most important endpoints such as cognitive functions or motor skills for your treatment approach in the best possible way.
  • Selection of suitable study parameters: An individual study protocol naturally also requires that any study parameters are also adapted to each situation. We determine the optimal treatment periods in order to obtain reliable and meaningful data and take into account influencing factors such as age, possible concomitant diseases and genetic predisposition so as not to be surprised when evaluating the data.

Effective patient recruitment

Recruiting suitable patients is particularly challenging in neurology. Thanks to our many years of experience in the field of clinical research, we have developed special patient recruitment strategies over the years. We are very familiar with the challenges of recruitment and have always successfully assisted trial centers in selecting the most representative patient population possible. Our techniques include:

  • Analysis of the target population based on the selected inclusion criteria such as cognitive abilities
  • Coordination with selected neurologists, specialized clinics and self-help groups
  • Continuous patient education and motivation, as well as awareness campaigns for relatives and those affected
  • Targeted advertising campaigns via specialist medical portals and social media

Efficient project management

Conducting clinical trials requires a high level of coordination and expertise at all times in order to adequately respond to any variables and potential risks. Through our experienced project management team, we help to ensure that your study is completed efficiently, on time and within budget. Seamless integration of all parts of the project is particularly important to us and we offer:

  • An interface for transparent communication between all parties involved
  • Flexible resource management, adapted to your requirements
  • Use of state-of-the-art technologies to record and analyze the study parameters
  • Rapid response to unforeseen events

Precise data management

Our data management team is always on hand to help you collect comprehensive data sets and ensure that all parameters are accurately recorded and subsequently analyzed. In close cooperation, we provide you with the collected data promptly and thus enable efficient evaluation. We guarantee this:

  • State-of-the-art technology
  • Rigorous control and professional handling of all collected data
  • Use of validated tools such as MMSE (Mini-Mental Status Examination) and UPDRS (Unified Parkinson Disease Rating Scale)
  • Precise evaluation of data for interim reports
  • Close cooperation with monitoring for the best data integrity

Clinical monitoring

Our high-quality monitoring ensures the quality and integrity of the data collected in your studies, paying particular attention to the challenges within neurology. We offer you:

  • On-site visits to check that all treatments and patient visits are being carried out correctly
  • Remote monitoring for prompt checking of patient diaries, for example
  • Central monitoring to identify trends and respond to them immediately
  • Training for investigators to ensure standardized assessment of neurological symptoms at all trial sites

Clear and precise reporting

At the end of your neurological study, we provide you with a thorough and transparent evaluation of the data collected. We prepare meaningful study reports for you in a timely manner, focusing on the key clinical findings. We focus on the criteria discussed during study planning (e.g. quality of life, cognitive or motor skills), while also taking into account individual adjustments that were necessary or desired during the course of the study. With these reports, we offer you a sound basis for further planned regulatory applications – in which we are also happy to support you – and also for a successful market launch of your product.

Regulatory support from start to finish

As a team, we support you in all regulatory procedures that you may encounter in the course of your product life cycle – from the initial application to the final approval on the market for neurological treatments, you can count on us. We are familiar with the specific regulatory requirements that particularly affect neurological studies and can therefore take these into account from the very beginning of study planning. Together, we find suitable endpoints, define safety parameters and take into account potential influences that could reduce the success of a therapy, thus ensuring that we successfully overcome regulatory hurdles at the first attempt. We support you in communicating with the authorities and prepare you optimally for any remaining queries. We want to make the approval process for your product as efficient as possible and identify, address and avoid potential obstacles at an early stage.

Place your trust in our expertise

Benefit from our specialized experience in the field of neurology. We are aware of the major challenges and special features of clinical studies in this field and have already successfully supported numerous projects. Now we would like to bring your project to fruition and work with you to change the future of neurological treatment.

And what can we do for you?

Uwe_Albrecht

Dr. (MD) Uwe Albrecht,
FIBMS, FFPM (Dis.), FICR, CSci

Managing Director

Hauptsitz_Mediconomics

Head office

Hanover

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