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
Transtherapeutic 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
