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rOur company bets on research, development and innovation in Advanced Therapies, showing the sanitary and scientific commitment P-Value has achieved with its social environment

"P-Value Medical contributes to the generation of knowledge in Advanced Therapies"

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P-Value Medical offers you the possibility of monitoring in any Spanish province at a flat rate.

Travelling costs are always the same so that you will always know exactly how much you will have to pay for a monitoring visit without having to worry about how much prices can vary for travelling to the different participating centres.

Our mission is to make things easier for you and to enable you to adjust your budget with no last minute surprises.

CRP-Value Medical is an independent Contract Research Organization (CRO).

P-VALUE MEDICAL is an independent Contract Research Organization whose main aim is to encourage and provide exceptional research services to our clients. Our commitment is to help Pharmaceutical research, diagnostic and biotechnology companies to develop clinical trials and other pertinent studies in order to introduce their products or their new indications in the market.

P-Value Medical complies with current European regulations and the ICH Guideline for Good Clinical Practice for carrying out and designing clinical trials. P-Value Medical has developed its own Standard operating procedures which guarantee its scientific and methodological rigour. P-Value Medical commits itself to the quality and confidentiality of each client.

All our efforts are directed towards a final objective, the complete satisfaction of our clients through our total quality guarantee. To that end we work to exceed our clients’ expectations as regards quality, time and cost of their projects. Our team, infrastructures, and professional vocation ensure the efficient fulfilment of all the goals which are necessary for the project to be successful.

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+ROWe can offer our clients a wide range of services starting from the initial approach to the Project up to and including the diffusion of results. This is how we promote and lighten the load of investigational work, based on the most up-to-date scientific evidence and the latest technologies.

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Protocolrotocolwritingwriting

?What P-value Medical intends when offering its services of writing and adapta-tion of protocols is to establish a direct relationship with the promoter in order to establish the hypothesis, specify objectives, determine the study population and sample size necessary to achieve conclusive results, define eligibility criteria, give assessment as regards the methodology of the project, and the trial period necessary to verify the hypothesis…

Demonstrable experience over years of collaborating in the following types of trials with different levels of clinical evidence:

- Phase II-IV clinical trials - Post authorization studies - Investigational projects

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At the beginning of the project P-Value Medical develops, designs and offers advice on the CRF whose objective is to record all of the information required by the protocol

Depending on the client’s preferences and project necessities the CRF can either be:

A paper based Case Report Form.

An electronic Case Report Form: data bases with a web interface - This allows for data input from anywhere with an Internet connection and for the promoter to visualize recruitment and project follow up at any moment, as well as being able to obtain preliminary results during the trial. - It makes monitoring easier since all the data introduced by the investigator can be visualized on line. - Generation, management and resolution of queries.

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Clinical trials, post-authorization and non-pharmacological observa-tional studies

LegalBased on the evaluation of overhead costs

Financial

Population size, hypothesis, possible biases, variables…

Statistics

To establish the design of the trial, phase, necessary controls, type of blind…

Methodology

Discussion on the use of a placebo, infant population…

Ethical

P-Value’s highly qualified staff allows us to carry out evaluations and advise our clients as regards the different areas related to clinical investigation:

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Custom - Made InvestigationGrupo P-Value

mmanagementanagement

mmanagementanagement Before starting a clinical trial it is necessary to be aware of and comply with all the pertinent procedure established by current legislation concerning clinical trials and post-authorizations studies for their evaluation by the competent authorities: Ethics committees The Spanish Medical Agency Regional/Autonomic Communities

Once all the pertinent authorizations have been obtained the following steps are necessary: Negotiation of contracts with the Centres Choosing investigators

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Custom - Made InvestigationGrupo P-Value

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P-Value Medical takes part in the selection of Centres and Investigators which are usually those with whom we have previously collaborated on other projects.

In accordance with good clinical practice and the company’s internal SOPs, P-value’s staff is highly qualified to carry out the different visits to the Centres ensuring data quality and guaranteeing ethical requirements. Selection visits Meetings with Investigators Initiation visits Monitoring visits Close-out visits Distance monitoring

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Custom - Made InvestigationGrupo P-Value

DataDatamanagement

DDataatamanagementmanagement P-Value Medical designs specific databases for each trial. This facilitates the monitoring process, quality control of the information and its posterior statistical analysis.The data input forms are identical to those of the CRF so avoiding the entry of erroneous information.

In order to maintain the confidentiality of the information passwords must be used to access the application.P-Value Medical has its own data quality system consisting of: Double data entry. Cleaning process Generation of queries.

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Once the trial results have been obtained, P-Value Medical together and in close contact with the promoter/client will decide how to carry out: Type of analysis Statistical report Clinical report Abstracts Publications

In writing the above mentioned reports P-Value Medical will follow the directives established by “ICH Harmonised Tripartite Guideline“ as regards the Structure and Content of Clinical Study Reports.

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ttrainingraining Clinical investigation: Training in EC: legislation, principles, protocol writing, monitoring… Training in post-authorization studiesStatistics: Databases Fundaments of biostatistics. SPSS packets

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P-Value Medical has wide experience in the execution of clinical trials on an international level. Our qualified profes-sionals guarantee the fluidity of the coordination and progress of each phase of the study.

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Custom - Made InvestigationGrupo P-Value

Regulatory Regulatory pharmacovigilanceissuesissues

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RRegulatory egulatory pharmacovigilancepharmacovigilance&

issuesissuesThe services provided by P-Value Medical regarding this issues are:- Creation of Pharmacovigilance planning- Definition of the type of product regarding regulatory requirements (Health Products, medicines, cell drugs…)- Definition of the process for registration.- Development plan (quality, preclinical and clinical) following current legislation requirements (including guidelines)- Supervision of quality guidelines compliance in the different development phases (procedures of correct manufacture, Good Laboratory Practice…)- Authorizations for pharmaceutical laboratory- Scientific Advice- Monitoring of relevant Authorizations- Implementation of Quality Systems and Management Systems of R+D (including rules of the serial UNE 166.00x)- Policies and strategies definitions of R+D (including advertisement)

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44

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ctAvd. San Fco. Javier 22

Edificio Hermes, Planta 1ªMódulo 14 41018

Sevilla

C/ José Abascal 444ºD 28003

Madrid

www.grupop-value.com

902 012 292

Raúl Martín AcostaRaúl Martín AcostaMobile: 665 677 802Key Account [email protected]