Medical Writing - Data Management - Biostatistics
Scientific Events - Consulting & Training - Real World Data
reative Pharma & HR Services Medical Affairs team comprises of talented professionals of both PhD and MD background with extensive academic and pharma industry experience, across all major therapeutic areas, who are committed to providing state of the art services of the highest quality covering all stages of clinical research and aspects of medical affairs.
CPHS Medical Affairs through its quality driven and results oriented approach, aims at cultivating long lasting collaborations and partnerships based on trust, quality performance and transparency.
CPHS Data Management and Statistics team, consisting of an experienced multidisciplinary group, with the support and consultation of academic units, can provide you with flexible and accurate data management and innovative data analysis solutions (incl. quality insights) of the highest caliber and for the most demanding projects.
Maximum efficiency and competitive pricing within agreed timelines is the added value CPHS Medical Affairs brings to its clients.
CPHS Medical Affairs can accommodate partial or full medical writing projects of all levels of complexity while operating under a rigorous quality assurance system (ISO 9001, ISO/IEC 27001) to ensure the highest quality of deliverables in accordance with up to date regulatory requirements through ongoing internal reviews and audit controls.
Clinical Study/Trial documents
CPHS Medical Affairs experienced professionals can ensure the success of any clinical program by developing/editing/reviewing documents including:
CPHS Medical Affairs can develop/edit/review in accordance with the ICH-GCP and PPG guidelines a well-designed submission-ready study protocol, adhering to the risk-based approach as described under the EU NO 536/2014 Regulation of the European Commission.
CPHS Medical Affairs can develop/edit/review ICFs and patient information leaflets, including pediatric ICF documents in accordance with the ICH-GCP guidelines and incorporating the local requirements of competent authorities.
CPHS Medical Affairs can design and integrate PROs into a clinical trial protocol. PROs are important in clinical development as they reflect patients’ perspectives on the effectiveness of the treatment and its impact on their quality of life, functional status, psychological and social well-being, compliance to regimen, utility of healthcare resources, symptoms and satisfaction. Partnering with CPHS can bring the added value of PROs to your product portfolio, helping you maximise their differentiation and impact.
CPHS Medical Affairs can develop and review clinical study reports in accordance with the International Council for Harmonization (ICH) Structure and Content of Clinical Study Reports (E3) and all the relevant requirements and guidelines.
CPHS Medical Affairs is committed to deliver well-designed, robust, protocol driven CRF’s with the focus in obtaining high quality data for the study’s endpoints.
Promotional & Educational material
CPHS Medical Affairs can fully undertake or provide medical writing support in collaboration with KOLs and Subject Matter Experts for the development of promotional and educational material, in accordance with the SFEE code of conduct, aimed at physicians and/or the public including:
- Promotional material for your entire product portfolio
- Medical Brochures describing disease epidemiology, the unmet medical & patient needs
- Medical Brochures aimed at physician guidance regarding guidelines, preferred practices, consensus statements and Standard of Care treatment
Regulatory Medical Writing
CPHS Medical Affairs can support the following regulatory activities:
- Common Technical Document (CTD) updates (2.4 Clinical overviews, 2.5 non-clinical overviews, 2.6 Clinical Summaries, 2.7 Non Clinical Summaries)
- Medical Devices (Clinical Evaluation Reports)
- Product Monographs
Publications & Other Scientific documents
CPHS Medical Affairs team comprises of high caliber PhD experts with extensive academic and pharma industry background, available to undertake or support any of the following activities:
- Development of original manuscripts, systematic reviews and case studies for scientific journal publications
- Preparation of abstracts, posters and presentations for conferences
CPHS Medical Affairs translation team is committed in delivering medical translations of the highest medical/scientific terminology accuracy. Customized translation libraries for each therapeutic area are created to suit the needs of each client assuring consistency across documents.
The integrity of clinical data is of the utmost importance for a successful project. The success of a clinical study or research project relies heavily on the ability to answer questions that help you to improve the quality of patient outcomes and reduce costs. Make the most out of your clinical data — whether it’s quantitative, qualitative or transactional — and at the same time, gain access to your study status with our clinical data management services.
CPHS Data Management team provides services as data collection, recording, data quality control, database development as well as system design and design of supportive software. The experienced, interdisciplinary CPHS Data Management team ensures that your data is recorded with speed, integrity and accountability. The team works closely with CPHS customers to identify specific requirements/needs for each study/project. Its main goal is to ensure the reliability of data across a wide range of treatment areas, creating the appropriate database for the final analysis.
CPHS Biostatistics team, incl. statistical programming, provides services as statistical analysis and processing to pharmaceutical companies, researchers and healthcare professionals. In addition, the Biostatistics team offers consulting and educational statistical services in collaboration with university units. Together with the Data Management team, they are working to deliver efficient data collection services and innovative data analysis solutions with the key objective of high quality. The personalized approach ensures that the designated and offered solutions are tailored to the individual needs of each study/project.
Our Data Management & Statistics team are in the process of training in the use of Data Standardization (CDISC).
- Flexibility of electronic data capture (EDC) system solutions for you study,
- EDC implementation best practices,
- Design and development of electronic Case Report Form (eCRF)
- Design and development of Data Management Plan (DMP)
- Database set-up (design, development and validation) for both paper and electronic CRF based studies
- Single and Double data entry
- Data validation and query resolution
- Data cleaning
- Integration and transfers of external third-party data
- Database lock
- Study/project design (incl. power analysis, sample size calculation, population definition)
- Generation of Randomization list
- Design and Development of Statistical Analysis Plan (SAP) and Statistical Analysis Reports (SARs)
- Statistical programming (incl. tables, figures and listings)
- Data preparation for statistical analysis – creation of derived variables
- Statistical analysis of results (incl. interim, final, ad hoc)
- Interpretation of study/project results and writing support for manuscripts
- Statistical Consulting
PHS Medical Affairs can support your advisory boards from concept creation to delivery of detailed minutes, consensus statements / executive summary and the final report. We offer you peace of mind as we are also able to manage the event and logistics organization including contract arrangements.
(Type B events)
PHS medical affairs can provide full support Type B events according to the SFEE code of practice. This service includes undertaking the organization of the event, including speaker material/presentation preparation, minutes and final report development.
Conferences with Scientific Content
(Type A events)
PHS medical affairs can provide full coverage and deliver the summary of key presentations according to the client’s requirements for any Type A event of all major therapeutic areas including Oncology, Pulmonology, Endocrinology & Metabolic disorders, Infectious diseases, Rheumatology, Cardiology, CNS disorders, Ophthalmology, Gastroenterology.
CPHS Medical Affairs can tailor its training service capability so as to develop customized training material and/or deliver training across all major therapeutic areas. Examples include training leaflets, presentations, and workshops that aim in combining the application of newly learned skills into practice, with creating a common purpose, drive and motivation for the participants.
CPHS Medical Affairs can generate real world data insights in order to bring value to your full product development spectrum. CPHS can provide comprehensive services through the use of Patient Reported Outcomes (PROs) in observational studies, helping you generate real world evidence (RWE) that will support the value of your medicinal product.