1a

• Technology-driven innovation (under the influence of the development of science – the market is not ready for the product)
• Market-driven innovation (as a result of market surveys, the market expects the product)
• Replacement of existing product
• Product related to cost reduction
• Radical new product
• Other, what…

The innovation potential of this product is related to technology-driven innovation.

MnemoKairos has been indeed designed  in order to manage and monitor different kind of clinical information in a digital way. It has been a way to answer to a specific CRO need.

1b

Compared with the currently used methods, MnemoKairos is an high-quality database.

Thanks to this database, it is now possible to record, analyze and report clinical and financial information about all clinical trials conducted.

1c

A designed database for the management of all kind of information about Clinical Trials.

2a

National ¨

European ¨

Global þ

Please describe the characteristics of your target market.

The target market of MnemoKairos is global. MnemoKairos could be introduced by every Institute, in order to harmonise clinical information, as the European Union requires.

Clinical trials performed in the European Union are indeed required to be conducted in accordance with the Clinical Trials Directive.

There are a number of guidelines specifying various aspects of clinical trials, and in particular:

• The information to be submitted to the competent authorities and to the ethics committees
• The requirements on safety monitoring and the reporting of adverse reactions
• The requirements regarding Good Clinical Practice, including the documentation, of the clinical trials
• The specific requirements regarding the products and the clinical trials
• The inspections of competent authorities and the applicable procedures.

2b

• Base – applied by all companies in the industry

• Leading – applied by a single or limited number of competitive companies

• Key –at a development stage, but has already proven its potential

The product can be characterized as base because it could be applied by a lot of companies in the industry, after a specific development.

There are probably other databases similar to MnemoKairos, produced by big ICT players, that can be adapted to different fields (medicine, engineering, …)

2c

• Existing demand – the market is already developed

• hidden (latent) demand – the market has yet to be developed

The product satisfies an existing demand of precision, monitoring and availability of clinical data. The most important objective of MnemoKairos is the improvement of the human resources productivity.

2d

• Implementation, implementation in production (leading to a radically new product offers)

• Growth (rapid spread within the industry or outside it)

• maturity (parameters of the technical characteristics of manufactured products reached their maximum, higher-grade products can be manufactured on the basis of technological substitution)

The current stage of the product’s market life cycle is Growth.

Database can’t be considered a new product, even if MnemoKairos has various specific features like: data centralization, modularity, platform portability, real-time reporting, ….

2e

3a

• the description of a phase II-IV adult clinical trial where the investigator sites are in European Union member states and the European Economic Area;
• the description of any paediatric clinical trial with investigator sites in the European Union and any trials which form part of a paediatric investigation plan (PIP) including those where the investigator sites are outside the European Union.

The details in the clinical trial description include:

• the design of the trial;
• the sponsor;
• the investigational medicine (trade name or active substance identification);
• the therapeutic areas;
• the status (authorised, ongoing, complete).

Some information are not available, like:

• information on the results of clinical trials;
• information on non-interventional clinical trials of medicines (observational studies on authorised medicines);
• access to the authorisation document from the national medicine regulatory authority or the opinion document from the relevant ethics committee;
• information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures;
• …..

According to these guidelines, there are companies that produce a similar database.

In order to have a more precise competitor analysis, we should consider also the ICT companies that design and develop databases.

3b

• lower prices based on lower production costs

• product differentiation (uniqueness of the product proposal)

The competitive advantage over the competitors indeed is the combination of the features of the database.

3c

• High price range

• Average price range

• Low price range

The potential price policy is average price.

3d

• To regulated markets (e.g. heat supply, water supply, universal telecommunication services, agricultural products, fishing industry, architectural services)

• To markets operating on the principle of free negotiation between agents on the market

The product will been marketed to free markets.