Thomson Reuters can provide a comprehensive range of pharmaceutical communication support, from publication planning to medical writing, all tailored to the needs of the global pharmaceutical community. Our services span drugs, devices and biologics.
Our industry experts can help you fashion your clinical and non-clinical data - no matter what the scope and quantity - into concise, industry-standard formats that communicate the essential information to your target audience quickly, accurately, and in the language they expect.
Benefit from industry communication professionals.
With Thomson Pharmaceutical Services, you can:
- Stay informed on the latest drugs, trials, news stories and patents.
- Develop regulatory strategies and identify submission options.
- Design preclinical and clinical documentation.
- Plan and prepare for regulatory authority meetings.
- Develop protocols, case report forms and consent forms.
- Prepare and e-file all components of the Common Technical Document (CTD).
- Undertake quality assurance audits of source documents and regulatory submissions (print and electronic).
- Develop databases, data entry, validation and coding, conversion and output.
Why choose Thomson Pharmaceutical Services?
- Regulatory writing: We specialize in assisting in the preparation of all aspects of regulatory submissions, from individual non-clinical and clinical study reports to integrated summaries of safety and efficacy.
- Data management: Thomson Reuters has made a significant commitment to the eResearch Technology (eRT) platform of integrated data management software. This 21CFR-compliant suite provides the IT infrastructure needed to support small Phase I studies through to the most sophisticated Phase III studies.
Quality assurance and auditing : We provide cost-effective quality assurance support that can save your company time and money by identifying potential problems early in the drug development process. Using a variety of auditing tools, we validate the procedures, assumptions, and data that support the regulatory acceptability of your clinical and non-clinical programs. We offer a constructive approach and an informative style allowing for early institution of quality checks and balances. - Regulatory consultancy: We can help you navigate the regulatory hurdles associated with new drug development and facilitate approval of submissions by international regulatory authorities.
- Investigational New Drugs: Writing support for pre-IND FDA meetings , chemistry, manufacturing, and controls compliance, non-clinical study reports and summaries, clinical experience summaries, non-US clinical experience summaries, Investigator's Brochures, pharmacology, toxicology, and ADME.
- Investigational New Drugs: Writing support for pre-IND FDA meetings , chemistry, manufacturing, and controls compliance, non-clinical study reports and summaries, clinical experience summaries, non-US clinical experience summaries, Investigator's Brochures, pharmacology, toxicology, and ADME.
- Electronic Submissions: Experience in working with document management systems and save your company time and money as we take care of the preparation and filing of Investigational New Drug, Abbreviated New Drug, and New Drug Applications.
- Common Technical Documents: Full support for all phases of CTD writing and publishing.
- Standard Operating Procedures: Expert assistance in successfully designing, preparing, and maintaining clinical and regulatory SOPs, including process engineering consulting.
- Regulatory Mop-up: The support needed to complete clinical study files and "mop-up" clinical programs: data management, data analyses, preparation of clinical study reports and clinical study synopses, and more.
Contact Us
Thomson Reuters
101 Gibraltar Road,
Suite 200
Horsham, PA 19044
Tel:+1 (215) 328-4560