ADKNOMA - Corporate Presentation

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Your Clinical Research project PARTNER

BARCELONAMartí i Julià, 6-8 Entlo. 3ª dcha.08034 BARCELONA

MADRIDCapitán Haya, 1 15ª planta

28020 MADRID

Project Management, Study Design, Regulatory Affairs, Data Management, Monitoring, Biostatistics, Communication, Information Technology (eCRF)

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01Company02Services

03Clients 04Contact

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C01Company

ADKNOMA is a CRO with broad experience and extensive knowledge of clinical research project requirements.

We provide our clients with leadership strategy in all our projects, and work to ensure that outsourcing our services represents an real benefit and added value.

We see quality as a differential value in the projects in which we participate, having obtained ISO 9001:2008 certification.

We work for the pharmaceutical industry, biotechnology firms and independent investigators, and meeting their objectives is a priority, so we form mixed teams that cover all the requirements that arise in all our projects.

We have been registering sustained growth since 2004. We now have offices in Barcelona and Madrid, and have agreements with CROs that enable us to undertake Phase I-IV projects both in Spain and on an international scale.

About us3

01Company

The teamThe company is formed by highly-qualified professionals who cover all the requirements arising in any clinical research project without the need for outsourcing

• Medical Management• Project Management• Design• Regulatory affairs• Information Technology• Monitoring• Data Management• Statistics• Medical Writing

Team members have an average of more than 10 years of cumulative experience in the development of clinical research projects in different therapeutic areas, particularly oncology, cardiovascular, CNS, transplants and infectious diseases.

We have an absolute approach to Management, so all our project managers follow a strict methodology that enables us to anticipate risks and establish quick communication channels with our clients, to inform them of how studies are progressing and make rapid decisions when necessary.

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BAM3.6%

Medicine3.6%

Health Sciences 50.0%Statistics

10.7%

IT 7.1%

Other 25.0%

Team experience

01Company

0 a 2 years

2 a 5 years

5 a 10 years

> 10 years

0% 5% 10% 15% 20% 25% 30% 35% 40%

Philosophy5

ManagementPartners

Quality

Communication

To develop clinical research projects, establishing Partnership relations with our clients, applying a strict Management Methodology, with efficient channels of Communication between all the participants and thorough Quality Control in all our work.

01Company

CSRThe ADKNOMA business strategy includes a Social Responsibility policy in relation to our employees and society.

Our greatest asset are the people who form part of the company, so we have developed reconciliation policies

that increase their commitment to ADKNOMA, reinforcing the quality of and their involvement in all the projects in which they participate, reducing rotation rates.

ADKNOMA is also sensitive to more vulnerable settings, so we participate in charity events and make annual donations to NGOs (both on a corporate and personal scale).

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01Company

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s02Services

ServicesADKNOMA has the capacity to develop any clinical research project, whether Trials (Phase I-IV) or Cross-Sectional or Observational Studies.

We adhere to strict Management methodology to achieve our clients’ objectives and establish fluid communications throughout the project to keep all participants informed of its progress. This model enables us to minimise risks and anticipate corrective action when necessary in order to ensure success in regard to both deadline and quality

Our mission is to add value to what we do for our clients, so our staff are constantly being trained. Our approach is completely CLIENT-ORIENTED, as we strive to understand their needs and provide the best solutions for each and every one of their proposals.

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02Services

Information technology

Clinical research

Clinical researchProject management

At ADKNOMA we believe that Project Managers play a very important role, because success depends to a large extent on his or her management methodology and monitoring.

Our professionals are from the clinical research field, but they have been trained in the management techniques and methods used in the consultancy field so that all our clients can be sure that the project covers its initially-defined scope, in relation to both deadline and costs, with the quality that has always characterised our company.

The services that we provide in this field are:• Single contact for project coordination• Definition of project objectives• Consultancy services on methods used to minimise risks• Project planning and initial project presentation to the client• Establishment of control and follow-up milestones• Periodic follow-up meetings to assess project compliance• Leadership of all aspects affecting the project• Coordination and support for the allocated project team• Meetings with investigators

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02Services

Clinical researchStudy design and regulatory affairs

This is a critical phase in all projects, because efficiently conducting the project depends to a great extent on meeting project deadlines.

Therefore, to ensure a smooth, problem-free regulatory phase, ADKNOMA has a highly experienced (more than 4 years on average) CTA department that closely monitors the entire process with a view to reducing the bureaucratic and contract formalisation period as much as possible.

During this phase, we maintain constant, fluid communications with our Clients in order to make decisions that enable us to start recruitment as soon as possible in all the selected sites.

We provide the following services in this phase:• Design

• Investigator selection• Clinical research study viability assessments• Literature search and protocol development• CRF/eCRF creation and design

• Regulatory• Application for requirements• IEC processing• AEMPS processing• Autonomous region processing• Service provider processing• Management of contracts with investigators, sites, etc.

02Services

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Clinical researchmonitoring

The members of the ADKNOMA monitoring department have an average of 5 years of experience as CRAs, enabling us to provide high quality in their work, anticipating situations and taking decisive action when necessary.

We have developed our own tool to control the progress of study monitoring, with a powerful alert system that prevents reporting deviations from occurring, while enabling the situation to be easily monitored by everyone involved in the study.

They are out of the office for 40-45% of the workday, so that they can provide high quality planning, monitoring and reporting.

The services provided in this area are:• Periodic bureaucratic status updates• Site and investigator selection• Physical monitoring • Remote monitoring• Query issue, management and processing

02Services

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Clinical researchdata management and study logistics

This is a critical stage of all projects, because efficiently conducting the project depends to a great extent on meeting project deadlines.

Therefore, to ensure a smooth, problem-free regulatory phase, ADKNOMA has a highly experienced (more than 4 years on average) CTA department that closely monitors the entire process with a view to reducing the bureaucratic and contract formalisation period as much as possible.

During this phase, we maintain constant, fluid communications with our Clients in order to make decisions that enable us to start recruitment as soon as possible in all the selected sites.

We provide the following services in this phase:• Design

• Investigator selection• Clinical research study viability assessments• Literature search and protocol development• CRF/eCRF creation and design

• Regulatory• Application for requirements• IEC processing• AEMPS processing• Autonomous region processing• Service provider processing• Management of contracts with investigators, sites, etc.

02Services

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Clinical researchBiomedical communication

• Dissemination of knowledge.• Integration with user or patient associations.• Drafting of and/or consultancy services regarding the content of presentations.• Drafting scientific papers.• Preparation of other presentations (posters, slides, etc.). • Leaflets, press releases, etc.• Literature review reports.

02Services

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Clinical researchbiostatistics

• Sample size calculation.• Centralised or online randomisation.• Creation of analytical plan.• Fraud detection.• Statistical processing of clinical studies.• Statistical reports.• Clinical/statistical reports.• Presentations of results.

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02Services

Information technologyeCRF, management platforms, development of CR

At ADKNOMA we believe that the future of clinical research must be supported by computer tools that show the progress of studies in real time, and are of value for all involved.

This area is very important for us, so we work with professionals widely experienced in critical solutions, who enable us to always provide the most innovative solutions for our Clients.

Our team includes members from the Information Technology Consultancy field who provide our Clients with new perspectives

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02Services

in the development of Clinical Research applications, providing solutions that are both useful and user-friendly for participating investigators.

Our eCRFs are technological platforms that provide much more information than a mere electronic case report form, reducing project time and increasing the quality of the information obtained, while remaining simple and easy to complete.

eCRF

Usermanagemen

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Alerts

Progress statistics

Communication portal

Document repository

Studyschedule

Anticipated results

statistics

DataAudit

Regulatory Status

Monitoring StatusPayment

management

Financial Status

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c03Clients

Pharmaceutical companies17

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Scientific societies18

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04Contactc

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04Contact

Barcelona

Madrid

c/ Martí i Julià 6-8 entlo. 3ª dcha.08034 BARCELONA

Tel. 93-206.66.66Fax 93-206.66.67

[email protected]

c/ Capitán Haya, 1 planta 1528020 MADRID

Tel. 91-417.70.90Fax 91-418.43.31

[email protected]

www.adknoma.com