Aepodia is a team of experts with more than 15 years

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1 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 Investigational Medical Product and Device Phase I/II Project Management and Clinical Strategy Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Safety and Pharmacovigilance Pharmacovigilance Study Monitoring Biomarker Recommendations and 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 0009_ADAPTATION_PLAQUETTE.indd 2 Aepodia is your partner providing expertise Study Management and Reporting Aepodia SA Rue Louis de Geer, 6 B-1348 Louvain-la-Neuve BELGIUM Aepodia France SARL Avenue du Canada, 3 Z.I. de Courtaboeuf F Les Ulis FRANCE in Early Clinical Development and customized services in Phase I/II Clinical Trials. Tel : +32 (0) Tel : +33 (0) Fax : +32 (0) info@aepodia.com

2 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 Investigational Medical Product and Device Phase I/II Project Management and Clinical Strategy Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Safety and Pharmacovigilance Pharmacovigilance Study Monitoring Biomarker Recommendations and 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 0009_ADAPTATION_PLAQUETTE.indd 2 Aepodia is your partner providing expertise Study Management and Reporting Aepodia SA Rue Louis de Geer, 6 B-1348 Louvain-la-Neuve BELGIUM Aepodia France SARL Avenue du Canada, 3 Z.I. de Courtaboeuf F Les Ulis FRANCE in Early Clinical Development and customized services in Phase I/II Clinical Trials. Tel : +32 (0) Tel : +33 (0) Fax : +32 (0) info@aepodia.com

3 SCIENTIFIC CONSULTANCY CLINICAL OPERATIONS > Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept > Clinical Study Set-up > Biomarker Recommendations and Implementation > Study Management and Reporting > Translational Scientific Consultancy > Study Monitoring 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. 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. 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. 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. Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner s activities. 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. 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. > 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). 0009_ADAPTATION_PLAQUETTE.indd 3

4 SCIENTIFIC CONSULTANCY CLINICAL OPERATIONS > Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept > Clinical Study Set-up > Biomarker Recommendations and Implementation > Study Management and Reporting > Translational Scientific Consultancy > Study Monitoring 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. 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. 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. 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. Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner s activities. 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. 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. > 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). 0009_ADAPTATION_PLAQUETTE.indd 3

5 SCIENTIFIC CONSULTANCY CLINICAL OPERATIONS > Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept > Clinical Study Set-up > Biomarker Recommendations and Implementation > Study Management and Reporting > Translational Scientific Consultancy > Study Monitoring 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. 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. 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. 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. Aepodia supports clinical trials by implementing and supervising trials, monitoring safety, biomarkers performance, and other key parameters including coordinating other partner s activities. 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. 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. > 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). 0009_ADAPTATION_PLAQUETTE.indd 3

6 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 Investigational Medical Product and Device Phase I/II Project Management and Clinical Strategy Preclinical and Clinical Drug Development Plan Strategy up to Proof of Concept Safety and Pharmacovigilance Pharmacovigilance Study Monitoring Biomarker Recommendations and 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 0009_ADAPTATION_PLAQUETTE.indd 2 Aepodia is your partner providing expertise Study Management and Reporting Aepodia SA Rue Louis de Geer, 6 B-1348 Louvain-la-Neuve BELGIUM Aepodia France SARL Avenue du Canada, 3 Z.I. de Courtaboeuf F Les Ulis FRANCE in Early Clinical Development and customized services in Phase I/II Clinical Trials. Tel : +32 (0) Tel : +33 (0) Fax : +32 (0) info@aepodia.com