It does not work without YOUR input

 

Before a new medicinal product is introduced to the market, safety, efficacy and tolerability have to be tested. YOU have the experience with your product and we have the experience how to bring YOUR product to YOUR planned market.  

LaNova Consulting one step ahead
LaNova Consulting                             one step ahead

Consulting for SMO and CTU

A Clinical Research/Trial Unit (CTU) within a Hospital and/or Hospital Group operates as a Site Management Organization (SMO), which is an organization that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or a clinical site.

 

A Clinical Research Unit generally centers on coordinated research, conducted according to subject-appropriate principles.

A Clinical Research Unit thus offers a high degree of flexibility in terms of its structure and objectives.

 

The main focus of the Clinical Research Unit is to perform high-quality and innovative research which will benefit current and future patients. All studies has to be carried out in accordance to Good Clinical Practice (GCP) and established Standard Operating Procedures (SOP).

 

Clinical Research Units promote the development of networks for disease- or patient-oriented (translational) clinical research and the long-term implementation of scientific working groups within clinical institutions. Clinical Research Units pursue clinical investigations, integrate clinical findings, and may conduct clinical pilot studies. Thematically they focus on translational research with patient-oriented approaches and on understanding disease mechanisms.

 

Clinical Research Units share the following features with other Research Units:

 

  • Clinical Research Units are medium-sized research groups set up by the scientists involved.

 

  • Each Clinical Research Unit consists of a manageable number of projects and other funding modules that all deal with the same subject and that can only be worked on as a group in the proposed manner. To facilitate close collaboration, proposals should generally not encompass more than ten projects.

 

  • The main feature of a Clinical Research Unit is collaboration across projects. Clinical Research Units are  led by outstanding scientists with international track records and project experience.

 

  • Clinical Research Units bring together the disciplines relevant to research on the topic at hand.

 

The topic chosen by a Clinical Research Unit must be current and relevant. Its underlying concept must be highly innovative and coherent, thus justifying medium-term planning of between six and, in exceptional cases, eight years.

The criteria for evaluating scientific excellence that apply under the Individual Grants Programme also apply to a Clinical Research Unit and its individual projects.

Clinical Research Units offer ideal conditions for young scientists.

 

LaNova Consulting has the knowledge (miracle of curiosity, competitiveness, cooperation, and collaboration) and experience of success for the process of initiating a Clinical Research  Unit, for deciding on study topics, and finally for bridging the gap between clinical and research staff as well as Hospital and Sponsors (Pharma, MedDevice Industry).

 

The professional practice of LaNova Consulting to support and supervise all involved hospital staff (medical & administrative) and at the end the hospital will benefite from the increased academic rigor and productivity.

 

Please refer to the recent publications which describes the benefits in details.

Sponsoren gesucht, f&w 04.2012

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Verschenktes Potential, f&w 04.2014

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