Catalogo medical-english

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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.

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Catalogo medical-english

  1. 1. Custom - Made Investigation
  2. 2. AdvancedAd c ddv TherapiesesTr Our 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"
  3. 3. ) Monitorization )) torizMonitor withoutdistancthoutdistances 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.
  4. 4. CR P-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. TheCompany
  5. 5. +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. +v ++RORO++OO++v ROO+RO++O+RO+RO+O+
  6. 6. ???Custom - Made Investigation Grupo P-Value Protocolrotocol writingwriting
  7. 7. ?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 PProtocolrotocol writingwriting Custom-MadeInvestigationGrupoP-Value 9
  8. 8. Custom - Made Investigation Grupo P-Value CRFCRF designdesign
  9. 9. CRFe- CRF* * ccase reportase report 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. alue Medical designs specific ranP-Va - omization software for each trialdom form (CRF) designform (CRF) design Custom-MadeInvestigationGrupoP-Value 13
  10. 10. Custom-Made Investigation Grupo P-Value cconsultancyonsultancy
  11. 11. cconsultancyonsultancy Clinical trials, post- authorization and non- pharmacological observa- tional studies Legal Based 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: Custom-MadeInvestigationGrupoP-Value 17
  12. 12. Custom - Made Investigation Grupo P-Value mmanagementanagement
  13. 13. 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 Custom-MadeInvestigationGrupoP-Value 21
  14. 14. Custom - Made Investigation Grupo P-Value mmonitorizationonitorization
  15. 15. 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 mmonitorizationonitorization Custom-MadeInvestigationGrupoP-Value 25
  16. 16. Custom - Made Investigation Grupo P-Value DataData management
  17. 17. DDataata managementmanagement 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. Custom-MadeInvestigationGrupoP-Value 29
  18. 18. Σ α θ℮℮℮℮℮Σ ℮ ± θθ℮℮ ± Σ αα Custom - Made Investigation Grupo P-Value RReport ofeport of resultsresults µ | |Σα α ℮± ± ρ χ²
  19. 19. µ | Σα α ℮℮℮Σ ℮±℮℮±±℮±± ±± Σ± ρ±± ρρ χ² ± ρ χ ±± χ ± χ² ρ RReporteport resultsresults ofof 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. Custom-MadeInvestigationGrupoP-Value 33
  20. 20. µ Σα α ℮Σ ±℮℮ ± Σαα ρΣ ±± χ² ±± ρρ±±
  21. 21. Custom - Made Investigation Grupo P-Value ttrainingraining
  22. 22. ttrainingraining Clinical investigation: Training in EC: legislation, principles, protocol writing, monitoring… Training in post-authorization studies Statistics: Databases Fundaments of biostatistics. SPSS packets Custom-MadeInvestigationGrupoP-Value 37
  23. 23. hellohallo hol hola ciao holol ciao bonjour hallo hallo oc bonjour hello hel iai o ( ‫ﻢ‬‫ﻼ‬‫ﺴ‬‫ﻠ‬΃ hallo ha bonjo onjo Custom - Made Investigation Grupo P-Value iinternationalnternational experienceexperience )) hello hallo hola hola ciaociao bonjour bonjour )(‫΃ﻠﺴﻼﻢ‬
  24. 24. hellohallo hola hola ciao hola ciaiao olol cia ciao bonjour halloonj o r ci u bonjour bonjour hello bonjou ia ur o uur ii r onjour llj bon hh bbo‫ﻢ‬‫ﻼ‬‫ﺴ‬‫ﻠ‬΃ hallo ‫ﻢ‬‫ﻼ‬‫ﺴ‬‫ﻠ‬ ‫ﻼ‬‫ﺴ‬‫ﻠ‬΃ bonjo b ‫ﻼ‬‫ﺴ‬‫ﻠ‬΃‫ﻠ‬΃ oo‫ﺴ‬‫ﻠ‬΃ jj ‫ﻠ‬΃ ‫ﻼ‬‫ﺴ‬‫ﻠ‬ jojo ΃ ‫ﻢ‬‫ﻼ‬‫ﺴ‬ oo ha ‫ﻢ‬‫ﻢ‬‫ﻼ‬hh iinternationalnternational experienceexperience 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. Custom-MadeInvestigationGrupoP-Value 41
  25. 25. hello hallo hola hola ciao hola iociciao bonjour allo j oc bonjour bonjour hellob j ia r o ourrbonj hhbbonjo llj (‫ﻠﺴﻼﻢ‬΃ hallo ‫ﻠﺴﻼﻢ‬ bonjo ‫ﻼ‬ ‫΃ﻠ‬ h ‫ﻢ‬‫ﻢ‬ hh ‫ﻼ‬ ΃‫ﻠ‬ jj ‫ﻠ‬‫ﻠﺴﻼ‬ oo ΃ o ΃
  26. 26. Custom - Made Investigation Grupo P-Value RegulatoryRegulatory pharmacovigilance issuesissues &&
  27. 27. RRegulatoryegulatory pharmacovigilancepharmacovigilance& issuesissues The 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) Custom-MadeInvestigationGrupoP-Value 44
  28. 28. ontact Avd. San Fco. Javier 22 Edificio Hermes, Planta 1ª Módulo 14 41018 Sevilla C/ José Abascal 44 4ºD 28003 Madrid www.grupop-value.com 902 012 292 Raúl Martín AcostaRaúl Martín Acosta Mobile: 665 677 802 Key Account Manager raulmartin@grupop-value.com

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