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OUR SERVICES


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Biostatistics



  • Clinical trial development plan
  • Power/sample size estimation
  • Statistical analysis plan
  • Table shells
  • Data mapping specs
  • Randomization schedule
  • Interim analysis and DMC Support
  • ISS/ISE report
  • Real world data analysis and statistical support
  • Bioinformatics services


Statistical Programming



  • Development of SDTM/ADaM
  • TFL creation and validation
  • Programming support for patient profiles and patient narratives
  • Support for CSR, ISS/ISE, Interim
  • Support to regulatory, publication
  • Support database edit checks, query
  • Support of Data Monitoring Committee
  • Data mining, support for exploratory analysis and real world data analysis
  • Prepare e-submission package
  • CDISC implementation
  • Legacy data conversion to SDTM
  • Annotating CRF pages
  • Define.pdf or Define.xml
  • Study data reviewer’s guide
  • Analysis Data reviewer’s guide
  • Submission of XPT datasets
  • Submission of programs
  • Final e-submission package


Data Management



  • Data Management Plan (DMP) creation
  • Database development
  • Data entry and cleaning
  • External data loading and reconciliation
  • SAE reconciliation
  • Dictionary coding
  • Database lock
  • EDC (Oracle Clinical)
  • EDC account management
  • EDC training and support


Medical Writing



  • Protocols and amendments
  • Clinical Study Reports (CSRs) and patient safety narratives
  • Investigator brochure updates
  • Common technical document (CTD) overview and summaries
  • Integrated analyses of effectiveness (ISE) and safety (ISS)
  • Agency briefing packages
  • Informed Consent Forms (ICF)
  • Publications (abstracts, posters, manuscripts)
  • Submission-ready capabilities (electronic publishing): Fully hyperlinked and bookmarked documents


Regulatory



  • Global Regulatory Strategies
  • Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.)
  • CMC (Chemistry, Manufacturing, Control)
  • Labeling
  • Translations of Technical Documents
  • Coordination of Regulatory Certificates


Clinical Operations and Management



  • Site Feasibility and Selections
  • Site Contract and Budget Negotiation
  • Site Startup Activates
  • Site Monitoring Visit
  • Site Management and Documentations
  • Medical Monitoring and Patient Safety Review
  • Pharmacovigilance Services
  • Study Budget and Timeline Management
  • TMF Management


OUR FLEXIBLE SERVICE MODEL





We can serve in roles as CRO that works on deliverable basis

  • Work in our office and on our system that is compatible with yours
  • Acquire services ‘as needed’
  • Significantly reduce your budgeting and management efforts
  • Provide fast response and quickly mobilize to assist with projects behind schedule
  • Advanced technology and tools that are compatible with your system


We can serve in roles equivalent to your external team

  • Work off-site on your system or our system that is compatible with yours
  • Can be your team members and work as FTE on the scopes with your assignment
  • You have direct access/manage our FTE resources
  • You are welcome to play a key role in the establishment of our study team
  • The study lead is employed by us, but has a solid line to your manager
  • You may utilize our expertise and knowledge (such as expert statisticians and expert programmers) beyond the assigned team members, if it is necessary

We provide the opportunity to harmonize standards and integrate into the sponsor’s system



ABOUT US





A growing CRO with a global footprint in U.S. and China


Building strategic partnerships or preferred vendor relationships with pharmaceutical companies, biotechnology companies and CROs


Flexible service models with experienced staff to deliver high quality products for your CSR, regulatory submission, or publication


Full commitment to excellence with our expertise, experience and passion to enable you to get to market faster, reducing time and cost



THERAPEUTIC AREA EXPERTISE





  • Oncology Immunology/Autoimmune
  • Rare Disease/Orphan Drug
  • Anti‐Inflammatory/Pain
  • Neurology/CNS
  • Cardiovascular
  • Gastroenterology
  • Ophthalmology
  • Allergy
  • Vaccine
  • Anti‐Infective
  • Diabetes & Metabolic Disease


CONTACT INFO





Address: 220 Davidson Ave, Suite 201, Somerset, NJ 08873



Phone number: (908) 223-8823



Email: info@deltamedcro.com



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