Drug Development Consulting
Experienced Drug Development Consultants to assist you in all phases
Drug Development Consulting
Experienced Drug Development Consultants to assist you in all phases
Pharma IT has an experienced team of Drug Development Consultants ready to assist you with services in all phases – from early phase clinical development, to late phase, and well into the post-marketing phase
We currently cover the following specialty areas with our own experienced consultants.
Click to learn more about services provided in each area.
Benefit from a tailored solution that meets your needs
Our drug development team includes experienced consultants, expert scientists, and bright young talent. We can tailor a solution, that meets your needs and budget, to help you ensure safe and compliant drug development.
Pharma IT has an experienced team of Drug Development Consultants ready to assist you with services in all phases – from early phase clinical development, to late phase, and well into the post-marketing phase
We currently cover the following specialty areas with our own experienced consultants.
Click to learn more about services provided in each area.
Benefit from a tailored solution that meets your needs
Our team includes experienced consultants, expert scientists, and bright young talent. We can tailor a solution, that meets your needs and budget, to help you ensure safe and compliant drug development.
Our collective experience uniquely positions us to contribute specialist perspectives, experience, and efficiency
We are our customers trusted advisors and partners. Pharma IT has a full suite of services to aid you in your drug development processes – and the competencies to support your products once they are placed on the market. Our impressive team of senior experts combined with rising talents can support you in a flexible way no matter the complexity or therapeutic area. Plus, our IT competences allow us to assist you in making all of your processes as digitalized as you prefer.
Birgitte Sloth
Pharma IT Insights
in Drug Development from our team
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Our collective experience uniquely positions us to contribute specialist perspectives, experience, and efficiency
We are our customers trusted advisors and partners. Pharma IT has a full suite of services to aid you in your drug development processes – and the competencies to support your products once they are placed on the market. Our impressive team of senior experts combined with rising talents can support you in a flexible way no matter the complexity or therapeutic area. Plus, our IT competences allow us to assist you in making all of your processes as digitalized as you prefer.
Birgitte Sloth
Want to know more about how Pharma IT's Drug Development Team can help you?
Reach out to learn more about our service offerings
Want to know more about how Pharma IT
can help you?
Reach out to learn more about our drug development service offerings
We can also offer Clinical Data Management and Biostatistics services via our partners and our extensive freelance consultant database
Pharma IT can assist you with consulting services to support clinical trial data management and biostatistics during early drug development and post market clinical commitments.
- Protocol Development
- Paper/eCRF and database design
- Data Management Platform (DMP) Development
- Database Testing & User Acceptance Test
- Data entry and validation
- Discrepancy Management
- Clinical data surveillance
- Protocol deviations review
- Serious Adverse Event (SAE) reconciliation
- External and third party data reconciliation
- Quality control
- Database Lock & Freeze
- ePRO, eCOA and device data integration
- SAS and SQL programming
- Data mining and migration
- CDISC SDTM standards
- MedDRA/WHODrug coding
- Risk based monitoring
- TMF Support & Documentation
- Submission and DM representation in inspections and audits
- Vendor management
- Project management and Data management oversight
- Accurate and complete database quality assurance checks
- Accurate and consistent data for statistical analyses
- Statistical analysis plan
- Accurate and timely statistical input into reports or decisions
- Valid analysis strategies
- Accurate and consistent statistical tables, figures and data listings
- Accurate report text
- Consistent summary tables in the body of reports and the corresponding source tables and listings
- Statistical methods section reports
- Accurate interpretation of results
- Consistent presentation and interference
- Adherence to report guidelines
- Project-wide consistency