Clinical Research

After the active phase of a clinical trial, data are all that remain. DataClin has the expertise and knowledge about this critical phase in clinical research. This leads to presenting high-quality, reliable, and statistically sound data from clinical trials.

Our Clinical Data Management team has records of achievements this industry spanning over many therapeutic areas and almost all clinical research phases in addition to post-marketing product registries and diseases registries. We realize the importance of minimizing time needed for executing data management steps -from CRF development to Database Lock- while ensuring the maximum quality of data which keeps our clients ahead of the competition by means of faster publications/product commercialization.

Our team works according to a full set of standards including local and international guidelines in addition to DataClin SOPs and sponsor’s SOPs. All data management steps are subject to regular quality audits conducted by highly qualified auditors and accordingly a continuous process of updates. We conduct Electronic Data Capture (EDC) studies and paper based studies as per sponsor’s request.

• Data Management input in study outlines and study protocol
• Case Report Form (CRF) design, development and annotation
• CRF completion guidelines and investigator’s training
• Data management plans including; data validation and self evidence correction plans
• Database design, build, validation and testing (paper or EDC)
• Edit-checks (validation rules) design, development and testing
• Paper CRFs tracking and imaging
• Clinical Data Entry (Independent double data entry or single entry with 100% review)
• Discrepancies management
• Data Extracts, listings and reports
• Manual/ medical review of listings
• Medical Coding
• SAE reconciliation
• Final Database Quality Audit
• Paper CRFs archiving
• Project Management and Mock-up reports
• Data Mangement training and consultancy

DATACLin’s Biostatics team is experienced and skilled in a board range of therapeutic areas. They can help you to design, implement, evaluate and provide reporting of any Phase (I-IV) of clinical trials and health surveys and also to select the most appropriate design to meet the objectives of your study in accordance with the relevant regulatory bodies’ requirements.

Our Biostatistical services can be customized to your individual needs ranging from statistical analysis plan and sample size calculation, to an in-depth Biostatistical support.

DATACLin team will partner with your organization every step of the way.

Biostatistics Services

• Protocol Development/ Aspects of clinical trial design
• Sample Size Calculations/ Statistical power determination
• Statistical consulting/ Regulatory and advisory meeting support
• Data Monitoring Committee (DMC) support including committee selection, statistician representation, and charter preparation
• Randomization Schedule Preparation (Fixed/ Interactive)
• Statistical Analysis Plan (SAP) Development
• Statistical Tables, Listings and Graphs
• Interim Analysis/ Preliminary Analysis
• Statistical Analyses/ Results interpretation and presentation
  • Topline Analysis Package (delivery within 3 business days of database lock)
  • Final Analysis Package (delivery within 10 business days of database lock)
• Statistical Review of Clinical Study Reports (CSR)
• Pooled analyses
• Meta-analyses
• Data mining/ Exploratory analyses
• Integrated Summaries of Safety and Efficacy (ISS/ISE)
• Quantitative epidemiology including patient registries

We Reduce Time to Market through optimization of all aspects of the clinical trial process and functional areas. We reduce risk through milestone and performance-based agreements to move your product to the next stage towards approval within budget.

Dataclin Clinical Operations team conducts Phases II-IV clinical trials in various therapeutic areas for pharmaceutical and biotechnology companies, maintaining the highest standards of ethics, quality and confidentiality.

stic tests are used to detect, confirm, or rule out the presence of a disease or medical condition. They can be used to screen for certain conditions in people who are at increased risk; to evaluate the effects of treatment; or to monitor disease progression.

For Clinical Operation, we provide the following solutions:

• Flexible Outsource Module
• Study Feasibilities (Country, Protocol & Site)
• Regulatory Submissions through All MENA Region
• Project Management
• Monitoring
• Site Management
• Medical Devices Studies
• Support for Biological & Bio-similar Studies.
• Support for Genetics Studies
• Support for Late-Phase Studies

DataClin Team ensures that representation and interpretation of study results are consistent with the study protocol and statistical outputs. Our medical writers are committed to develop high-quality documents that comply with regulatory, journal, or other guidelines in terms of content, format, and structure. We believe that a well-structured protocol is the backbone of a good clinical trial and that a good clinical study report is the mirror reflecting all steps of study planning and conduction in addition to study results.

For Medical writing, we provide the following solutions:

• Protocol Development
• Informed Consent Form
• Cytogenetics (Karyotyping and FISH)
• Interim efficacy and safety reports
• Clinical Study Report (ICH-E3 compliant)
• Publications (medical writing, editing, graphs and visuals)
• Medical marketing materials
• Medical educational materials