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.
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 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
You do not have to worry about coordinating between different service providers. Protocol Design and CRF Design Site Selection Study Submission Site Initiation and Patient Recruitment Monitoring Data Management up to Database Lock Biostatistics, Analysis and Medical Writing
Our Investigator Database Our Site Selection SOP
Our CRAs are trained, experienced and very well versed with latest GCP and ICH regulations. No. of Clinical Trials by Year ( ) Currently running 27 clinical trials in different MENA regions
Our Clinical Monitoring Department
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 auditable GCP quality results.
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
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.
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. vTrial TM was in-house developed. It is actively maintained and updated by one of our data management strategic partners. 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)
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
The way others do it!
The way we do it! Safety Confidentiality Security Storage facility in Abou Rawash, Egypt
Documents and picked up Boxes are temporarily stored in facility Scanning, Indexing and Quality Assurance Images are then: Stored on digital media Uploaded to FTP site Stored in archive Documents are then: Stored at Record Center Destroyed Returned to Customer Our Record Management Work Flow
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.
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
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
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 Mahmoud Ibrahim Clinical Research Associate