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Clinical Research

[/vc_column_text][/vc_column_inner][/vc_row_inner][/vc_column][/vc_row][vc_row css_animation=”fadeInUp” rsclass=”clean” el_id=”section-general-diagnostic” el_class=”section section-general-diagnostic m-0″][vc_column rsclass=”clean” el_class=”container”][vc_row_inner rsclass=”clean” el_class=”mt-lg-4″][vc_column_inner rsclass=”clean” rsinner=”department-tabs js-department-tabs d-none7 d-sm-flex js-tests-mobile-carousel7 js-service-card-style2-carousel7″][vc_column_text rsclass=”clean” el_class=”department-tab active” el_id=”ClinicalDataManagement”][medin_icon icon=”icon-eye-5″ class=”department-tab-icon”]

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[/vc_column_text][/vc_column_inner][/vc_row_inner][vc_row_inner rsclass=”clean” el_class=”department-carousel js-department-carousel”][vc_column_inner el_class=”department-item” width=”1/6″ rsclass=”clean” el_id=”MedicalWriting”][theme_text_image_element tt_order=”1″ tt_outer_css=”mt-lg-4″ image=”3039″ tt_image_outer_css=”col-md-6 h-100 mb-2 mb-md-0 ch-img-fluid mt-1″ tt_text_outer_css=”col-md-6″ tt_full_css=”row mb-0″]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.

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• [medin_icon icon=”icon-check-mark-1″]Data Management input in study outlines and study protocol
• [medin_icon icon=”icon-check-mark-1″]Case Report Form (CRF) design, development and annotation
• [medin_icon icon=”icon-check-mark-1″]CRF completion guidelines and investigator’s training
• [medin_icon icon=”icon-check-mark-1″]Data management plans including; data validation and self evidence correction plans
• [medin_icon icon=”icon-check-mark-1″]Database design, build, validation and testing (paper or EDC)
• [medin_icon icon=”icon-check-mark-1″]Edit-checks (validation rules) design, development and testing
• [medin_icon icon=”icon-check-mark-1″]Paper CRFs tracking and imaging
• [medin_icon icon=”icon-check-mark-1″]Clinical Data Entry (Independent double data entry or single entry with 100% review)
• [medin_icon icon=”icon-check-mark-1″]Discrepancies management
• [medin_icon icon=”icon-check-mark-1″]Data Extracts, listings and reports
• [medin_icon icon=”icon-check-mark-1″]Manual/ medical review of listings
• [medin_icon icon=”icon-check-mark-1″]Medical Coding
• [medin_icon icon=”icon-check-mark-1″]SAE reconciliation
• [medin_icon icon=”icon-check-mark-1″]Final Database Quality Audit
• [medin_icon icon=”icon-check-mark-1″]Paper CRFs archiving
• [medin_icon icon=”icon-check-mark-1″]Project Management and Mock-up reports
• [medin_icon icon=”icon-check-mark-1″]Data Mangement training and consultancy

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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.

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Biostatistics Services

• [medin_icon icon=”icon-check-mark-1″]Protocol Development/ Aspects of clinical trial design
• [medin_icon icon=”icon-check-mark-1″]Sample Size Calculations/ Statistical power determination
• [medin_icon icon=”icon-check-mark-1″]Statistical consulting/ Regulatory and advisory meeting support
• [medin_icon icon=”icon-check-mark-1″]Data Monitoring Committee (DMC) support including committee selection, statistician representation, and charter preparation
• [medin_icon icon=”icon-check-mark-1″]Randomization Schedule Preparation (Fixed/ Interactive)
• [medin_icon icon=”icon-check-mark-1″]Statistical Analysis Plan (SAP) Development
• [medin_icon icon=”icon-check-mark-1″]Statistical Tables, Listings and Graphs
• [medin_icon icon=”icon-check-mark-1″]Interim Analysis/ Preliminary Analysis
• [medin_icon icon=”icon-check-mark-1″]Statistical Analyses/ Results interpretation and presentation
  • [medin_icon icon=”icon-check-mark-1″]Topline Analysis Package (delivery within 3 business days of database lock)
  • [medin_icon icon=”icon-check-mark-1″]Final Analysis Package (delivery within 10 business days of database lock)
• [medin_icon icon=”icon-check-mark-1″]Statistical Review of Clinical Study Reports (CSR)
• [medin_icon icon=”icon-check-mark-1″]Pooled analyses
• [medin_icon icon=”icon-check-mark-1″]Meta-analyses
• [medin_icon icon=”icon-check-mark-1″]Data mining/ Exploratory analyses
• [medin_icon icon=”icon-check-mark-1″]Integrated Summaries of Safety and Efficacy (ISS/ISE)
• [medin_icon icon=”icon-check-mark-1″]Quantitative epidemiology including patient registries

[/theme_text_image_element][/vc_column_inner][vc_column_inner el_class=”department-item” width=”1/6″ rsclass=”clean” el_id=”ClinicalDataManagement”][theme_text_image_element tt_order=”1″ tt_outer_css=”mt-lg-4″ image=”3043″ tt_image_outer_css=”col-md-6 h-100 mb-2 mb-md-0 ch-img-fluid mt-1″ tt_text_outer_css=”col-md-6″ tt_full_css=”row mb-0″]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.

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For Clinical Operation, we provide the following solutions:

• [medin_icon icon=”icon-check-mark-1″]Flexible Outsource Module
• [medin_icon icon=”icon-check-mark-1″]Study Feasibilities (Country, Protocol & Site)
• [medin_icon icon=”icon-check-mark-1″]Regulatory Submissions through All MENA Region
• [medin_icon icon=”icon-check-mark-1″]Project Management
• [medin_icon icon=”icon-check-mark-1″]Monitoring
• [medin_icon icon=”icon-check-mark-1″]Site Management
• [medin_icon icon=”icon-check-mark-1″]Medical Devices Studies
• [medin_icon icon=”icon-check-mark-1″]Support for Biological & Bio-similar Studies.
• [medin_icon icon=”icon-check-mark-1″]Support for Genetics Studies
• [medin_icon icon=”icon-check-mark-1″]Support for Late-Phase Studies

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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:

• [medin_icon icon=”icon-check-mark-1″]Protocol Development
• [medin_icon icon=”icon-check-mark-1″]Informed Consent Form
• [medin_icon icon=”icon-check-mark-1″]Cytogenetics (Karyotyping and FISH)
• [medin_icon icon=”icon-check-mark-1″]Interim efficacy and safety reports
• [medin_icon icon=”icon-check-mark-1″]Clinical Study Report (ICH-E3 compliant)
• [medin_icon icon=”icon-check-mark-1″]Publications (medical writing, editing, graphs and visuals)
• [medin_icon icon=”icon-check-mark-1″]Medical marketing materials
• [medin_icon icon=”icon-check-mark-1″]Medical educational materials

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Investigator training is an ongoing area for concern, and the Investigator Meeting is an optimal place to address these concerns and to ensure that your site teams are in compliance. DATACLin can provide content or logistical support for your Investigator Meetings, including key compliance and process training that is tailored to your study protocol.

Upon submitting your training request, you are given the opportunity to select from a set of options that fully match your requirements in terms of experience, background, cost, location, and language preference.

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