Genius is in Simplicity

Clever Life Science is a global technology services and solutions provider with the unique ability to make them fit perfectly to any R&D project needs.Our expertise as a Contract Research Organization covers Clinical Development, Post-Marketing and Epidemiologic studies across many therapeutic areas with the capacity to conduct any clinical trial

To look at the future of Clinical Research

and simplify it.

Since 1998, we’ve delivered and managed :

in all major therapeutic areas, from a single local study to programs spanning multiple continents.Our experience in solving the real-world research and development needs of top pharmaceutical, biotechnology, medical device, CRO and regulatory agencies, makes Clever Life Science an established and trusted actor.

30+ Oncology Studies

180+ Studies

70+ Cardiology

Studies

300 000+ Patients

50+ CNS Studies

25 000+ Sites

100+ Phase III/IV

Studies

50+ Countries and

languages

Genius eCRF

Genius ePRO/eCOA

Genius ePayment

The Clever Life Science Genius SaaS Clinical Research Solutions line is an easy to use, cloud-based clinical enterprise R&D solution that empowers clinical users and service providers with the components necessary for efficiently accelerating clinical research data from investigative sites and participating patients to clinical trial Sponsors worldwide.

Designed for the Rise of the e-PatientClever Life Sciences Genius SaaS Clinical Solutions Line

Clever Life Science Genius Solutions are built according to following standards:- IEEE830: Recommended practice for software requirements specifications- FDA 21CFR Part 11: Electronic Records, Electronic Signatures – Scope and Application- Guidance for industry: Computerized Systems Used in Clinical Investigations - Good practices for computerized systems in regulated “GXP” environments (PIC/S)- Audit trail

The Genius SaaS solutions are moving towards a unified, multi-component software architecture that would leave behind the cumbersome nature and expense of disparate, integrated solutions to significantly improve clinical operations by turning tactical task-driven manual processes into globally automated strategic processes.

Captures and delivers your data and allows you to obtain higher quality data faster with user-friendly and powerful tools (Social media, Study Portal,…).

Collects and Assesses Patient-Driven Data/Diaries over the Internet on any kind of devices in an intuitive and easy to use way.

Automate, Streamline and Centralize Site contracts and global payment process solutions. Genius ePayment provides on-demand access to reporting and analytics for both Project, Regulatory and Finance teams, forecasting, accruals and Sunshine Act disclosures.

Genius eDataWareHouse

Allows an easy integration with any other clinical solution (Oracle, Medidata,…), Sponsors IT systems (Clintrial, Business Objects), On Demand or automated data export (SAS, E2B,…) and big-data analysis.

Genius eAdjudication

Facilitates central management of adjudication activities. On-demand Clinical Endpoint Committees Workflow, Event report Form, electronic query tools and easy access to clinical and monitoring data for the Reviewers.

Data Management

Medical Data Coding

Infrastructure-as-a-Service (IaaS)

Software-as-a-Service (SaaS)

Study Branding

Study Portal

Regulatory

Biostatistics

Late Phase

Study Management

Epidemiology

Monitoring

Project Management

Pharmacovigilance

Functional Service Provider

Medical Writing

Clinical Operations

Safety

Monitoring

At Clever Life Science, comprehensive project coordination is the key to the success of your study. We have teams of experienced and well-educated project managers. Our project managers maintain an overview of all aspects of the study, working closely with the study team to ensure control of project scope, quality, budget and timeline in compliance with GCP and other regulationsClever Life Science’s commitment is a true partnership to facilitate meeting your goals and expectations from a CRO. We believe in working as an extension of your company with a complete and complementary team. Members with requisite expertise are assigned to each Project.

The Project teams provide the fundamental disciplines that are essential to the success of your project. Our enthusiastic, dedicated, and flexible Project Teams provide excellent strategy, clinical development, project management, customer service, and communications at all levels.

A Smart Differential ApproachServices

Data and SaaS solutions and Cloud-based applications are hosted and fully maintained by CLS on a highly secure, scalable, duplicated and resilient IT platform to ensure the highest integrity and availability standards.

Infrastructure management services and the tools to deliver these services are completely aligned to the IT Infrastructure Library (ITIL) guidelines.

CLS’s large datacenter is characterized by:

• Secure, reliable and high availability datacenter- 2 communication lines (principal optic fiber line up to 1Gb and a backup line)- 2 power generators with 2 weeks fuel reserve- Uninterruptible power supply

• 1500 sqm building on 3.7 acres surrounded by perimeter fencing

• 2 Backup Sites and 1 Recovery Site

• Biometry and controlled access

• Closed Circuit Television (CCTV) with technical support 24/7

• Separate compounds located within the company’s physical plant

• IT systems monitored 24/7

• Load balancing servers

• Fully climate controlled

• Robust data security (128 bits encryption, SSL and PKI)

• Duplicated architecture (RAID 5 servers).

Infrastructure

15 Rue d’AlsaceBP20 / 68250 ROUFFACH

France

Tél : +33 389 495 660Fax : +33 389 785 181

cls@cleverlifes.com

www.cleverlifes.com