NagyResearch -MEACRO is a full-service CRO operating in the Middle East and Africa.

1. NagyResearch-MEACRO is a full-service CRO operating in the Middle East and Africa. www.nagyresearch.com

2. International Presence NagyResearch-MEACRO is a leading multi-country CRO in the MENA region, with over 14 years of experience in Data Management and 5 years of experience in Clinical Monitoring and Clinical Trial Management.

3. MENA’s Local CRO NagyResearch-MEACRO acquired vast knowledge of the local clinical regulatory bodies and the procedures for rapid submission and approval. We have immense experience of the local day-to-day life and different cultures in MENA regions. Your trials will run smoothly and without any setbacks Kasr El Ainy street is one of Cairo’s busiest streets. The Egyptian Ministry of Health is located about 100meters away from here. It is home of Egypt’s Central Ethical Committee

4. Comprehensive Solutions You do not have to worry about coordinating between different service providers.

5. Our Services: Site Selection Our Investigator Database Our Site Selection SOP

6. Our Services: Monitoring Our CRAs are trained, experienced and very well versed with latest GCP and ICH regulations. No. of Clinical Trials by Year (2006-2009) Currently running 27 clinical trials in different MENA regions

7. Our Services: Monitoring Our Clinical Monitoring Department

8. Our Services: Data Management How do we handle our clinical trial data? Our Data Management team is using the most advanced clinical data management software available and according to the highest regulatory standards to ensure auditableGCP quality results.

9. Our Services: Data Management • Our Data Management Services include: • CRF Design • Database Design • Validation Rules • Double Data Entry • Electronic Data Capture (EDC) • Handling External Data (Import/Export) • Query Management • Dictionary Services (MedDRA & WHODD) • Quality Control • Serious Adverse Event Reporting • Database Lock • Statistical Analysis

10. Our Services: Data Management Our Data Management Infrastructure For Clinical trial data we use US-based validated GxP Data Centers. For internal company intranet and communication we use our own dedicated servers maintained by GoDaddy.

11. Our Products: vTrial-CTMS • Study and protocol management, design and tracking (epidemiology and longitudinal studies) • Site status tracking • Patient/CRF tracking, entry, and verification • Site initiation visits, close-out visits and audits • Flexible data entry including double data entry • Automated double data entry comparison and synchronization • Electronic and manual discrepancy identification and automated data queries (ADQ) generation • Paper and electronic CRF management • Serious Adverse Event (SAE) collection, processing, reconciliation and reporting • Robust query management capabilities • Automated edit checks and validation for compliances • Integrated medical coding references (MedDRA, WHO-Drug or Sponsor-developed) • vtrial™ is: • web-based clinical trial management software • Able to provide comprehensive functionalities • Flexible and user friendly • vtrial™ automates and streamlines workflow processes and increases the visibility of related tasks and data in a clinical study. vTrialTM was in-house developed. It is actively maintained and updated by one of our data management strategic partners.

12. Our Services: Data Management - EDC We can provide Electronic Data Capture facilities for the investigators on-site. • 4 years of experience with eCRF • Our vTrial-CTMS is full capable of capturing, processing and storing data • We keep daily backups • Our Disaster recovery plan is tested every four months

13. Our Services: Archiving The way others do it!

14. Our Services: Archiving The way we do it! Storage facility in Abou Rawash, Egypt

15. Our Services: Record Management Boxes are temporarily stored in facility Documents and picked up Scanning, Indexing and Quality Assurance Our Record Management Work Flow Documents are then: Images are then: Uploaded to FTP site Stored on digital media Destroyed Stored at Record Center Stored in archive Returned to Customer

16. Our Services: Analysis and Biostatistics Our statistical analysis solutions can be tailored per project’s specific requirements. In addition to our in-house Biostatistics team, we have strong alliances with multiple Biostatistics and Analysis service providers.

17. Our Services: Analysis and Biostatistics • Our Statistical Services include: • Study design, sample sizing, randomization and protocol writing/review • Data entry and data management (including tracking, validation checks & QC) • SAS programming and table, figure and listing production for study reports • Pharmacokinetic / Pharmacodynamic modeling • Regulatory submission support (including ISS and ISE data integration & analysis) • Statistical consultancy and DSMB statistical support

18. Our Services: Medical Writing • Since 1996, we have partnered with multi-national Pharma for over 200 medical writing and publication projects. • Our past projects span many therapeutic areas including: • Antibiotics • Autoimmune • Oncology • Cardiology • Diabetes • Neurology • Anti-thrombosis • Dermatitis • Pediatrics • Asthma • Osteoporosis

19. Contact Us We are happy to respond to your inquiries and quotation requests. For a free consultation on your project, please contact us: Dr. Magda Shafik Clinical Research Manager +20 12 3189 427 magda.shafik@nagyresearch.com Mahmoud Ibrahim Clinical Research Associate +20 17 4436 648 mahmoud.ibrahim@nagyresearch.com