SERVICES OVERVIEW
CROM Group offers a comprehensive spectrum of clinical research services to the pharmaceutical, medical device and biotech companies:
Clinical Operations
CROM Group can provide all the functions required to plan and execute a successful clinical trial from start to finish offering a 360° vision and a full service structure.
The company has a dedicated support team for its project managers providing rapid site activation for clinical trials, and continuous review and processing of site documents. Global and country-specific expertise is merged to ensure time saving and efficiency in study site recruitment and retention.
The company also recognises that whilst its 'full-service' model is perfect for many of its clients, some sponsors do not require all services. For this reason, CROM Group is delighted to provide either a full service, or distinct trial functions dependent on each client's individual needs.
Project Management
The Project Teams assigned to Sponsor's studies are selected according to Sponsor's needs which are carefully matched with CROM Group staff's experience. The company takes training extremely seriously and all staff follow continuous specific and personalised training programs. The team's already extensive knowledge is refined with study and sponsor specific training where needed and its job is supported by CROM Group's innovative technology.
Low staff turnover ensures that Project Team members typically remain constant throughout the duration of a study and the organisational structure allows direct communication with all levels of management and rapid response times. Teams are characterised by their expertise, seniority, competence, leadership, flexibility and their rapid problem solving capabilities.
Feasibility
CROM Group believes that a rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of accrual rate and therefore successful planning of trial milestones is impossible. If your last trial was delayed by recruitment issues, you may wish to consider the level of detail you were provided with in the feasibility assessment.
CROM Group strongly believes in “Quality by Design”: a determination to review from the very beginning all aspects of operations, with a view to avoiding problems rather than relying solely on the ability to react to issues when they arise. A detailed and reliable feasibility analysis is one of the crucial first steps in the process.
Site Selection
Central to success of any clinical trial is appropriate site selection. Having completed over 500 trials, CROM Group has close links to a large number of high quality, motivated investigational sites with high recruitment potential. The company's established presence ‘on the ground’ in these locations ensures that feasibility analyses are detailed and accurate, allowing Sponsors to select countries and sites optimally to meet their trial timelines.
Regulatory Affairs
Laws, regulations, directives, decrees, guidelines... each country has its own. CROM Group ensures that a Sponsor's studies are, and continue to be, fully compliant with this fast-changing world of rules in all of the countries that a study is being run in.
Clinical Monitoring
CROM Group's clinical monitors are chosen for their experience in Clinical Research and in the appropriate therapeutic area and also for their high level of commitment. They tend to be decentralised and based in the countries chosen for a clinical trial in order to reduce travel costs and increase efficiency.
The company's network of Clincial Monitors ensure and perform all activities related to pre-study/qualification visits, initiation visits, interim monitoring visits and close-out visits, ensuring compliance to the protocol and all regulatory requirements. They also maintain strong and constructive relationships with investigative sites to ensure successful study progress.
Pharmacovigilance
Guided by regulations and ethics, Pharmacovigilance is an absolutely critical activity for subject safety and for the success of a project.
In CROM Group, it begins prior to study start with a customized safety plan, continues through the study with the detection and assessment of adverse events and their registration, and moves on to their understanding and analysis.
CROM Group, through the expertise of its Pharmacovigilance Unit, provides accurate and real-time management of all safety issues both during a trial and post marketing. Experienced staff based both at headquarters and in the field are in constant and direct dialogue with physicians, the competent authority and the Sponsor to guarantee full control. CROM Group's staff are also certified EudraVigilance users.
Data Management and Biostatistics
CROM, through its associated company CROS NT, offers a complete service of data management and biostatistics. Electronic Data Capture (ECD) and Optical Character Recognition (OCR) capabilities are tailored to client's needs.
Quality Assurance
Quality management and quality assurance are kept under constant review and are assiduously implemented by CROM Group. Quality assurance is guaranteed through the integrated, certified quality system ISO 9001 first achieved in 2002 when few competitor companies had considered such accreditation important. The quality system is revised quarterly and thoroughly reviewed every two years by an external and independent auditor.
Logistics
Successful clinical trials are characterised by the efficient organisation and coordination of a great many separate and distinct processes. CROM Group expertly plans and constantly reviews the progress of each of these functions in order to ensure that each aspect delivers its intended outcome at the right time. This is the key to succesful trial logistics.
Drug Management
Depending on Sponsor's needs, a specialised CRO may be nominated to package and label investigational product followed by shipment to either local depots or study centres and subsequent destruction of unused product at the end of the study. CROM Group's project managers can supervise all or part of these activities depending on specific need, acting as point of contact for both the centres and the CRO or Sponsor, providing real-time resolution of issues.
Medical Writing
CROM Group, through its specialised staff and Clinical Research Physicians, offers a complete service of medical writing that includes the writing of study protocols (phase I-IV), case record forms and patient diary cards, preclinical and clinical study reports (ICH format), and documentation for congress exhibits (abstracts, posters and slide presentations, etc).
Legal
CROM Group, in person Oriana Zerbini, can be nominated as legal representative in Europe for companies outside the EU which do not have European legal representation.
Information Technology
CROM, through its associated company TECHORIZON Srl provides innovative informatics solutions for clinical trials tailored to meet client's needs. |
