Core Competencies

Clinical Medical Strategy

  • Drug Development, and Regulatory Approval Pathway
  • Drug Approval
  • Drug Launch
  • Medical Affairs and Life Cycle Management
  • Commercialization
  • Clinical trial design

Clinical Trial Execution

  • Trial Feasibility in USA, Canada, EU, Southeast Asia and Japan
  • Regulatory approvals
  • IRB, CA approvals
  • Study execution

Clinical Trial

  • Phase 1 - 4
  • Phase 1 QTc study in healthy subjects
  • Phase 1 QTc study in cancer subjects
  • International investigators selection
  • Site initiation
  • Site monitoring
  • Site co-monitoring
  • Clinical Trial management
  • Site close out
  • Clinical Development plan, Timeline and Budget

Clinical Safety Pharmacovigilance

  • End to End ARGUS implementation capabilities and PV activities.
  • Pharmaceutical Risk Management, strategic advice and analysis; develops US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMP’s) for Europe
  • Qualified Person for Pharmacovigilance (QPPV) – Provides QPPV services in the EU through its own on-staff personnel
  • Aggregate & Periodic Report, SUSAR, PSUR Writing & Submission- We ensure that reports, safety summary updates, risk assessment documents, and periodic reports are created in the proper format with the appropriate clinical content and oversight and submitted t
  • the relevant regulatory authorities within compliant timelines
  • Signal Detection – signal evaluation and management for clinical and marketed products, including label update analysis and physician review for any identified and potential signals
  • Case Processing – clinically trained, client-focused teams of safety specialists and supervising physicians receive and triage serious and non-serious AE cases, initiating the process of detailed case entry and follow-up, including case narrative writing, quality control checks, and medical review, t
  • enable on-time reporting within 7-day or 15-day requirements
  • Literature Search of adverse events for all types of products, using standard terms, triage analysis and relevant processing for expedited or periodic reporting

Medical Monitoring

  • Medical monitoring staff are trained medical directors provides support for safety studies as well as clinical expertise when interpreting adverse events

Medical, Clinical and Regulatory support

  • IND and NDA submission
  • IND holding for non- US companies
  • Experience team of writers with clinical medical and regulatory expertise to assist life science companies document efficacy and safety and stay in compliance worldwide throughout the product lifecycle
    • Expertise in IT-develops and executes integrated processes that facilitate the transfer of data and knowledge.
    • Expertise in preparation of complex reports.
    • Write Periodic Safety Update Reports (PSURs), PSUR Addendum Reports, Summary Bridging Reports, Development Safety Update Reports (DSURs), and US periodic reports

Professional Resource Services

  • ClinFomatrix provides strategic resources in Medicine, Drug Safety, Pharmacovigilance, Clinical Affairs, Medical Affairs, Clinical Operations, Medical , and Regulatory Affairs. Our specialties include contract staffing, strategic resourcing, and outsourcing solutions backed by offsite as well as offshore capabilities. Key staffing resources includes the following:
    • Senior Executives in Pharma; CEO, CMO, CSO, CTO
    • Medical Doctors
    • Pharmacovigilance & Drug Safety Associates
    • Medical Experts in Oncology, Hematology, Immuno-Oncology, Uro-Oncology, Cardiology, and Neurology
    • Clinical Research Associates
    • SAS Professional
    • Quality Control in Pharma

Strategic Consulting

  • Clinical Drug Development Consulting:
    • Clinical Study Design
    • Clinical Protocol Development, Protocol Wiring
    • Case Report Form
    • Informed Consent
    • Financial Disclosure
    • Oversight and leadership to the clinical group implementing clinical trials and to the project teams to ensure that corporate milestones are reached.
    • A liaison with potential clinical investigators and academia to conduct clinical trials
    • Medical expertise for selecting clinical investigators and sites, protocol and investigator brochure development, study and safety report writing and the writing of medical sections of regulatory applications
    • Medical monitoring, safety review of clinical trial data, application of stopping rules and regulatory expertise regarding AEs/SAEs and reporting
    • Organizing Advisory Board Meetings
    • Chief Medical Officer for start-up companies that lack full-time, in-house medical department but need an experience medical development leader
    • Data Safety Monitoring Board (DSMB) and Key Opinion Leaders
    • Advisory Board
    • FDA Oncologic Drugs Advisory Committee preparation
  • Regulatory Affairs Core Services:
    • Develop international regulatory strategic plans
    • Develop, write, compile, and review regulatory submissions, including IND, NDA, BLA, PMA, ANDA, CTA, IMPD, annual updates, risk management and pharmacovigilance
    • Review of CMC, preclinical pharmacology and toxicology documents
    • Provide regulatory support for clinical trials
    • Provide full regulatory support for key Milestone meetings and Regulatory Agencies
    • Train and advise personnel on regulatory requirements and topics
    • Manage regulatory inspections
    • Support post-marketing services including annual reports, field alerts, promotional material review, and manage risk management or evaluation programs.
    • Prepare and coordinate eCTD submissions
    • Annual IND, NDA and sNDA safety
    • FDA Oncologic Drugs Advisory Committee preparation
  • Imaging-To support image-intensive oncology trials
    • Write charters for imaging
    • Select image readers, reviewers and adjudicators
    • Adjudication
    • Site training for imaging
    • Image data management-Comprehensive Image Management Solution
    • Diagnosis
      • Reconcile image queries
      • Manage image quality

Recent Projects:

  • Phase 1, BA/BE studies, Drug Interaction Studies, Phase I, Dose Escalation Studies
  • Recruitment, Staffing across all areas
  • Assisting with Backlog of non-serious adverse events due to recent legislation
  • Provided Pharmacovigilance services for a Generic company product portfolio of 200 + products across North America, Europe
  • Phase 3 multicenter trials in 17 countries and a follow-up period of 6 months.
  • Monitoring the quality of study on an ongoing and monitoring of the quality of data
  • ARGUS Implementation and training
  • Phase 2 chemotherapy induced netropenia in breast cancer patients
  • Phase 2 chemotherapy, Head/Neck Cancer patients
  • Phase 2 chemotherapy, prostate cancer patients
  • Phase 3 chemotherapy, diffuse large B cell lymphoma patients
  • Phase 3 chemotherapy, soft tissue sarcoma patients
  • Phase 4 chemotherapy breast cancer patients