Aix Scientifics ® CRO - Planning and design of clinical research

Aix Scientifics^® Clinical Research Organisation

Planning and design of clinical research

The serious planning for the preclinical and clinical research is one of the most important tasks Aix Scientifics is concerned with. There are scientific, strategic, regulatory and logistical aspects to be considered. Planning begins with

research into the disease to be studied, their symptoms and consequences,
into the treatment options and their limits,
into relevant guidelines, policies, standards, regulations, etc.,
into the product to be investigated and alternatives,
into comparable clinical studies,
into the intentions and capabilities of the contracting authority (sponsor) and
research into the market and the (subsequent) competing products, and
into the possibilities of obtaining clinical knowledge in the specific case.

Based on this information, with the sponsor we develop a strategy for an appropriate and practicable approach. Objectives are:

to collect sufficient data for certification
in the European market (CE mark), the USA (FDA) and/or other markets and
to acquire additional data to differentiate the product in the market and
to get as much objective knowledge about the product as possible.

For each step (study) the following has to be fixed :

the parameters for measuring the success of treatment => primary Endpoints,
the inclusion and exclusion criteria,
the anticipated Adverse Events (AEs) (on the basis of a risk analysis),
the sample size of the study (based on statistical assumptions and calculation),
the assembly of participating clinical centres (considerations: <here>)
the modus of data collection and processing (paper / Internet),
the measures for quality assurance (e.g., monitoring, audits)
the logistics of the study (for products, clin. samples, information, and tools)
the leadership / management and monitoring of the study (e.g., by a Board)

In cooperation with the sponsor and investigators Aix Scientifics^® mostly designs study documents (including the protocol, the questionnaire (CRF), the patient information form, and if necessary instructions for diagnosis or sampling of probes). Other documents may typically be created by the sponsor (e.g. the information on the product). Usually, Aix Scientifics^® assembles the so-called Investigator's File.

The design of the study has major influence on the duration of the study, the quality of study data, and the charges incurred for the study, but ultimately also to the future prospects of the product in the market. It is worthwhile, therefore, to invest in a good design of the study. _E.G.F.