New services

Medical Communication

How to publish manuscripts in international journals?

    • Aimed to healthcare professional

    • Customized course, from 4 to 8 hours

    • Training topics edited by the journals with the highest impact index

Statistics for non statistics

    • Statistic comprehensible for non-statisticians

    • Aimed to clinical research professionals

 

Services

Medical Communication

Clinical documents

Study Protocols
Protocols for clinical trials from Phase II to Phase IV, epidemiological or observational studies

Case Report Forms
Case report forms (CRFs) design, patient questionnaires and diaries

Patient information
Patient Information Sheet, Informed Consent and Patient Brochures

Clinical Study Reports
Clinical Study Reports (CSRs) / interim reports according to local regulations and ICH E3 Guideline

IMPD / IND
Investigational Medicinal Product Dossier (EU); Investigational New Drug (USA)

Scientific communications/publications

Manuscripts & journal submission
Preparation and submission of scientific manuscripts for local and international medical journals. Review and editing of manuscripts in terms of journal instructions and suggestions of reviewers

Conference materials
Preparations of abstracts, slide sets and posters, including the submission to congresses and conferences

Meeting support
Presentations on scientific meetings, symposium slides and meeting minutes

Medical & scientific literature search

Product monographs and Clinical Trial Compendium

Pharmaceutical marketing

Designs
Scientific logos based on brand product
Illustrations

iPAD applications
Generation iPAD applications or other formats
Web content

Animations/flash presentations
Preparation of a 3D or 2D medical presentation

Videos
Mechanisms of action, 3D, interviews

Other medical communication
Literature review, white papers, KOLs meetings…

 

Statistical Services

Data management

Data bases
eCRF (external), creation of databases and databases lock tasks

Data management
Medical Dictionary for Regulatory Activities (MedDRA) coding, query generation and management

Data entry
Tools for data entry and data entry tasks for paper studies and data reconciliation

Statistical Services

Statistical inputs & reviews
Statistical sections of Study Protocols, CRFs, CSRs and manuscripts
Assistance in the development of scientific documents by providing statistical input

Sample size estimation
Sample size calculation according to published data

Statistical Analysis Plan
Elaboration and reviewing of Statistical Analysis Plan (SAP)

Programming of statistical analyses
Study tables, listings and figures using SAS or other statistical packages

Statistical Study Report
Statistical Study Report according to ICH E9 guideline

Statistical training
Courses of biostatics for non-statisticians and medical writers in collaboration with European Universities

Pharmacovigilance services

Safety Management Plan
Development of a study specific Safety Management Plan
Development and review of the clinical protocol safety section

Periodic Safety Updated Reports
Preparation and submission of Periodic Safety Update Reports (PSURs)

Patients Safety Narratives
Writing of safety narratives for CSRs

Data based reconciliation
Data reconciliation of safety and clinical trials databases

Pharmacovigilance Training
SAE training for investigators and monitors

 

Therapeutic Expertise

Our most extensive therapeutic experience includes the following areas:

Cardiovascular & Metabolic Diseases: pulmonary embolism, acute coronary syndrome, hypertension, hyperlipidemia, dyslipidemia, Type 1 and Type 2 diabetes

Immuno-Inflammatory: psoriasis, osteoarthritis, rheumatoid arthritis

Respiratory & Allergy: Chronic obstructive pulmonary disease (COPD), asthma, allergic rhinitis

Gastroenterology: Inflammatory bowel disease (IBD) and other gastrointestinal disorders

Central Nervous System (CNS): Parkinson’s Disease, Alzheimer’s Disease, schizophrenia, restless legs

Food supplements