aepodia is a team of experts with more than 15 years€¦ · we generate key documents such as the...
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Investigational Medical Productand Device
Phase I/II Project Managementand Clinical Strategy Safety and Pharmacovigilance
Preclinical and Clinical Drug Development Plan Strategy
up to Proof of Concept
Study Management and Reporting
PharmacovigilanceStudy Monitoring
Biomarker Recommendationsand Implementation Clinical Data Management Drug and Medical Device
Submission
Translational Scientific Consultancy Medical Writing Regulatory Support to EMA and Registration
Preclinical and Clinical Due Diligence Site Assessment and Audits Regulatory Submission Package
Scientific Consultancy Clinical Operations Regulatory Scientific Support
Aepodia is your partner providing expertisein Early Clinical Development and customized services
in Phase I/II Clinical Trials.Aepodia SARue Louis de Geer, 6
B-1348 Louvain-la-NeuveBELGIUM
Tel : +32 (0)10 39 20 11
Aepodia France SARLAvenue du Canada, 3Z.I. de CourtaboeufF-91940 – Les Ulis
FRANCE
Tel : +33 (0)1 60 92 70 90
Aepodia is a team of experts with more than 15 years experience in early clinical development and translational science with small startup and large global pharmaceutical companies. Aepodia’s team has been a preferred partner for major pharmaceutical and biotechnology companies for
more than 10 years.
Fully integrated Project Development Optimization and Coordination
Fax : +32 (0)10 39 20 99
0009_ADAPTATION_PLAQUETTE.indd 2 28/10/16 10:15
Investigational Medical Productand Device
Phase I/II Project Managementand Clinical Strategy Safety and Pharmacovigilance
Preclinical and Clinical Drug Development Plan Strategy
up to Proof of Concept
Study Management and Reporting
PharmacovigilanceStudy Monitoring
Biomarker Recommendationsand Implementation Clinical Data Management Drug and Medical Device
Submission
Translational Scientific Consultancy Medical Writing Regulatory Support to EMA and Registration
Preclinical and Clinical Due Diligence Site Assessment and Audits Regulatory Submission Package
Scientific Consultancy Clinical Operations Regulatory Scientific Support
Aepodia is your partner providing expertisein Early Clinical Development and customized services
in Phase I/II Clinical Trials.Aepodia SARue Louis de Geer, 6
B-1348 Louvain-la-NeuveBELGIUM
Tel : +32 (0)10 39 20 11
Aepodia France SARLAvenue du Canada, 3Z.I. de CourtaboeufF-91940 – Les Ulis
FRANCE
Tel : +33 (0)1 60 92 70 90
Aepodia is a team of experts with more than 15 years experience in early clinical development and translational science with small startup and large global pharmaceutical companies. Aepodia’s team has been a preferred partner for major pharmaceutical and biotechnology companies for
more than 10 years.
Fully integrated Project Development Optimization and Coordination
Fax : +32 (0)10 39 20 99
0009_ADAPTATION_PLAQUETTE.indd 2 28/10/16 10:15
SCIENTIFIC CONSULTANCY
> Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Aepodia develops the optimal early-phase clinical research strategy, evaluating all relevant data to establish a strong clinical development plan to enable quick and efficient Go/No Go decisions.
> Biomarker Recommendations and Implementation Aepodia uses Biomarkers and Pharmacodynamic/Pharmacological measurements to strengthen the design of clinical plans and to optimize decision-making processes for the development of your asset.
> Translational Scientific Consultancy Aepodia’s expertise in identifying and developing key experimental human disease models will help you in filling linkage gaps in animal and biological disease models (Translational Science).
> Preclinical and Clinical Due Diligence Aepodia is expert in providing Due Diligence evaluations for Pharmaceutical and Biotechnology companies from preclinical up to Phase II clinical data.
CLINICAL OPERATIONS
> Clinical Study Set-up Aepodia is a reliable and experienced full service provider for your early clinical programs. Aepodia handles activities such as feasibility, site identification, selection and contracting of vendors, as well as the coordination of the entire clinical trial application and submissions.
> Study Management and Reporting Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner’s activities.
> Study Monitoring Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site and/or remote monitoring visits throughout the study. They are specialized in complex Phase I & II studies.
> Medical Writing We generate key documents such as the IMPD, Investigator Brochure, Protocol, Integrated Clinical Study Report (according to ICH) and Briefing documents to support early clinical projects and trials.
> Site Assessment and Audits Aepodia is experienced in evaluating Phase I units, hospital-based investigational sites, and different vendors involved in clinical trials. Our evaluations are performed by qualified auditors in accordance with EMA and country-specific regulations.
> Clinical Data Management From the database and e-CRF development to database lock and data extraction, Aepodia performs all data management activities in respect to both the 21 CFR Part 11 requirements and the use of the Study Data Tabulation Model (SDTM) as defined by the Clinical Data Interchange Standards Consortium (CDISC).
PHARMACOVIGILANCE
> Aepodia’s highly qualified staff offers efficient, integrated, pharmacovigilance services for drugs and medical devices in clinical development. We have people experienced in the role of the Qualified Person Responsible for Pharmacovigilance (QPPV), who can help you with timely and accurate reporting to competent authorities of required documents for the clinical studies and projects we monitor, such as the Individual Case Study Report (ICSR) and Development Safety Update Report (DSUR).
REGULATORY (DRUG AND MEDICAL DEVICE)
> Aepodia prepares, coordinates and manages all the activities and documents needed for a successful clinical trial application of new compounds and devices. Our activities extend from medical writing to completing CTA and Ethic Committee specific forms and documents in various European Countries.
0009_ADAPTATION_PLAQUETTE.indd 3 28/10/16 10:15
SCIENTIFIC CONSULTANCY
> Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Aepodia develops the optimal early-phase clinical research strategy, evaluating all relevant data to establish a strong clinical development plan to enable quick and efficient Go/No Go decisions.
> Biomarker Recommendations and Implementation Aepodia uses Biomarkers and Pharmacodynamic/Pharmacological measurements to strengthen the design of clinical plans and to optimize decision-making processes for the development of your asset.
> Translational Scientific Consultancy Aepodia’s expertise in identifying and developing key experimental human disease models will help you in filling linkage gaps in animal and biological disease models (Translational Science).
> Preclinical and Clinical Due Diligence Aepodia is expert in providing Due Diligence evaluations for Pharmaceutical and Biotechnology companies from preclinical up to Phase II clinical data.
CLINICAL OPERATIONS
> Clinical Study Set-up Aepodia is a reliable and experienced full service provider for your early clinical programs. Aepodia handles activities such as feasibility, site identification, selection and contracting of vendors, as well as the coordination of the entire clinical trial application and submissions.
> Study Management and Reporting Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner’s activities.
> Study Monitoring Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site and/or remote monitoring visits throughout the study. They are specialized in complex Phase I & II studies.
> Medical Writing We generate key documents such as the IMPD, Investigator Brochure, Protocol, Integrated Clinical Study Report (according to ICH) and Briefing documents to support early clinical projects and trials.
> Site Assessment and Audits Aepodia is experienced in evaluating Phase I units, hospital-based investigational sites, and different vendors involved in clinical trials. Our evaluations are performed by qualified auditors in accordance with EMA and country-specific regulations.
> Clinical Data Management From the database and e-CRF development to database lock and data extraction, Aepodia performs all data management activities in respect to both the 21 CFR Part 11 requirements and the use of the Study Data Tabulation Model (SDTM) as defined by the Clinical Data Interchange Standards Consortium (CDISC).
PHARMACOVIGILANCE
> Aepodia’s highly qualified staff offers efficient, integrated, pharmacovigilance services for drugs and medical devices in clinical development. We have people experienced in the role of the Qualified Person Responsible for Pharmacovigilance (QPPV), who can help you with timely and accurate reporting to competent authorities of required documents for the clinical studies and projects we monitor, such as the Individual Case Study Report (ICSR) and Development Safety Update Report (DSUR).
REGULATORY (DRUG AND MEDICAL DEVICE)
> Aepodia prepares, coordinates and manages all the activities and documents needed for a successful clinical trial application of new compounds and devices. Our activities extend from medical writing to completing CTA and Ethic Committee specific forms and documents in various European Countries.
0009_ADAPTATION_PLAQUETTE.indd 3 28/10/16 10:15
SCIENTIFIC CONSULTANCY
> Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Aepodia develops the optimal early-phase clinical research strategy, evaluating all relevant data to establish a strong clinical development plan to enable quick and efficient Go/No Go decisions.
> Biomarker Recommendations and Implementation Aepodia uses Biomarkers and Pharmacodynamic/Pharmacological measurements to strengthen the design of clinical plans and to optimize decision-making processes for the development of your asset.
> Translational Scientific Consultancy Aepodia’s expertise in identifying and developing key experimental human disease models will help you in filling linkage gaps in animal and biological disease models (Translational Science).
> Preclinical and Clinical Due Diligence Aepodia is expert in providing Due Diligence evaluations for Pharmaceutical and Biotechnology companies from preclinical up to Phase II clinical data.
CLINICAL OPERATIONS
> Clinical Study Set-up Aepodia is a reliable and experienced full service provider for your early clinical programs. Aepodia handles activities such as feasibility, site identification, selection and contracting of vendors, as well as the coordination of the entire clinical trial application and submissions.
> Study Management and Reporting Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner’s activities.
> Study Monitoring Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites. Our CRAs conduct on-site and/or remote monitoring visits throughout the study. They are specialized in complex Phase I & II studies.
> Medical Writing We generate key documents such as the IMPD, Investigator Brochure, Protocol, Integrated Clinical Study Report (according to ICH) and Briefing documents to support early clinical projects and trials.
> Site Assessment and Audits Aepodia is experienced in evaluating Phase I units, hospital-based investigational sites, and different vendors involved in clinical trials. Our evaluations are performed by qualified auditors in accordance with EMA and country-specific regulations.
> Clinical Data Management From the database and e-CRF development to database lock and data extraction, Aepodia performs all data management activities in respect to both the 21 CFR Part 11 requirements and the use of the Study Data Tabulation Model (SDTM) as defined by the Clinical Data Interchange Standards Consortium (CDISC).
PHARMACOVIGILANCE
> Aepodia’s highly qualified staff offers efficient, integrated, pharmacovigilance services for drugs and medical devices in clinical development. We have people experienced in the role of the Qualified Person Responsible for Pharmacovigilance (QPPV), who can help you with timely and accurate reporting to competent authorities of required documents for the clinical studies and projects we monitor, such as the Individual Case Study Report (ICSR) and Development Safety Update Report (DSUR).
REGULATORY (DRUG AND MEDICAL DEVICE)
> Aepodia prepares, coordinates and manages all the activities and documents needed for a successful clinical trial application of new compounds and devices. Our activities extend from medical writing to completing CTA and Ethic Committee specific forms and documents in various European Countries.
0009_ADAPTATION_PLAQUETTE.indd 3 28/10/16 10:15
Investigational Medical Productand Device
Phase I/II Project Managementand Clinical Strategy Safety and Pharmacovigilance
Preclinical and Clinical Drug Development Plan Strategy
up to Proof of Concept
Study Management and Reporting
PharmacovigilanceStudy Monitoring
Biomarker Recommendationsand Implementation Clinical Data Management Drug and Medical Device
Submission
Translational Scientific Consultancy Medical Writing Regulatory Support to EMA and Registration
Preclinical and Clinical Due Diligence Site Assessment and Audits Regulatory Submission Package
Scientific Consultancy Clinical Operations Regulatory Scientific Support
Aepodia is your partner providing expertisein Early Clinical Development and customized services
in Phase I/II Clinical Trials.Aepodia SARue Louis de Geer, 6
B-1348 Louvain-la-NeuveBELGIUM
Tel : +32 (0)10 39 20 11
Aepodia France SARLAvenue du Canada, 3Z.I. de CourtaboeufF-91940 – Les Ulis
FRANCE
Tel : +33 (0)1 60 92 70 90
Aepodia is a team of experts with more than 15 years experience in early clinical development and translational science with small startup and large global pharmaceutical companies. Aepodia’s team has been a preferred partner for major pharmaceutical and biotechnology companies for
more than 10 years.
Fully integrated Project Development Optimization and Coordination
Fax : +32 (0)10 39 20 99
0009_ADAPTATION_PLAQUETTE.indd 2 28/10/16 10:15