Conducting clinical studies in such a difficult historical moment of great changes, such as the application of Regulation (EU) no. 536/2014, makes the construction of a solid, effective relationship with investigators even more important. This must be facilitated by the use of technologies that improve the precision and quality of processes and data cleansing.
All this, against a backdrop of projects whose field of application increasingly involves participation in international projects, represents the mission that our CRO has set itself for the years to come.
Tutto questo, in un panorama di progetti che sempre più hanno come terreno di applicazione la partecipazione a progetti internazionali, rappresenta la Mission che la nostra CRO si è data per gli anni a venire.
CD Pharma’s mission is use its structure to guide its Customers’ projects in achieving the set objectives, ensuring quality and precision.
We are constantly working on updating and training our resources and our objective is an ever greater focus on processes and computerisation to maintain a high quality level for our operating standards.
Unified vision of the clinical trial system
Centralisation of clinical study information: documents and data
Organisation focused on effectiveness and efficiency
Ongoing reporting
OUR CRO IS ABLE TO SUPPORT ALL PHASES OF A CLINICAL STUDY
always in compliance with the ICH/GCP/ISO 14155 guidelines, applicable regulations and reference SOPs.
Our expertise relates to managing interventional and observational clinical studies and coordinating activities for pathology registries. Specifically, we can support our customers in the following activities:
Defining synopses
Writing protocols
Feasibility
Clinical Project Management
Trial start-up
Monitoring activities
Medical writing
Investigators’ meeting
Statistical activity and data management
e-CRF customisation
Hosting and security
Support in scientific publications
SELF-CERTIFIED AT AIFA IN COMPLIANCE WITH THE MINIMUM REQUIREMENTS SET OUT BY THE ITALIAN MINISTERIAL DECREE OF 15/11/2011
STANDARD OPERATING PROCEDURES
The CD Pharma CRO has an internal Standard Operating Procedure system that regulates all the processes concerning a Clinical Study: from the start-up phase to data collection to the production of the final clinical report (CSR).
The development and use of Standard Operating Procedures is key to the effectiveness of the ISO 9001-certified Quality Management System, and guarantees that each individual belonging to the organisation will receive the information necessary to carry out their duties correctly, thus ensuring that the processes comply with technical requirements as well as regulatory dictates.
Skill CoordinationSince 2006
TARGET MARKET
Our main target markets are:
Pharmaceutical companies
Medical device companies
Hospitals
Study groups
Scientific associations
THERAPEUTIC AREAS
The therapeutic areas in which we have gained experience are:
Allergology
Cardiology
Dermatology
Haemophilia
Gastroenterology
Infectious disease
Neurology
Oncological hematology
Oncology
Pneumology
Rheumatology
One of the biggest challenges that those involved in clinical research must face is managing all the stages of a study, from planning to carrying out the various activities to managing the budget. In order to respond to this need, CD Pharma has preferred to build its own management system (CTMS) in house, designing it and adapting it to its own requirements and operational methodology.
The system has been expanded and completed with a validated eTMF section, for the conservation of essential documents. Both systems have been developed following the indications and satisfying the needs of the Clinical Operations department and, consequently, creating a specific system that meets the actual management needs of your CRO.
eCRF SOFTWARE VALIDATION
CD Pharma uses web-based software belonging to the Electronic Data Capture category which offers the following functions without any type of installation:
• Design of the eCRF and database
• Data collection and integrated reporting
• Issue of clinical queries through to the management of any data changes as part of clinical data management processes
• Electronic signature of the PI on the eCRF of each patient
The software programs for implementing eCRFs have requirements defined within:
ICH Topic E6 – Guidelines for Good Clinical Practice – (CPMP/ICH/135/95)
Guidance for Industry – Computerized System used in Clinical Investigations
21 CFR part 11 – Electronic Records and Electronic Signature
The system validated according to these principles guarantees:
• Access control
• Audit trail
• “ALCOA-C” (attributable, legible, complete, original, accurate and contemporaneous) data
• Standard operating procedures for the use of the computerised system
• Documentation that identifies which software and hardware are used by the computer systems that create, modify, store, retrieve or transmit clinical data
Validation evidence is part of the study documentation and is always available for inspection.
Here are the clients we have worked for:
AbbVie
Amgen
Angelini
Alfasigma
Almirall
Alvimedica
Bristol-Myers Squibb
CSL Behring
Dompè
ECRIN
Gilead
GlaxoSmithKline
Lofarma
Mediolanum Farmaceutici
Mylan
Nestlè Italia
Pfizer
Proxenia
Stallergenes
Sorin group