INTERNATIONAL FULL SERVICE BIO-DIGITAL CRO
BioRep and AdvicePharma work synergistically to provide a full range of Contract Research Organisations – CRO services for the organisation of clinical trials, the management of related data and the management of biological samples.
BioRep, with almost 20 years of experience in logistics, management and storage of biological material at a global level and thanks to its corporate organisation, provides important support in the design and management of clinical trials promoted on behalf of the Sponsor. Our stakeholders are mainly pharmaceutical and biotechnology industries, governmental institutions, foundations and universities.
Competence, speed and efficiency make BioRep a reliable partner for the reduction of clinical trial start-up times with consequent reduction of costs.
Advice Pharma is a Contract Research Organisation (CRO) that provides innovative services based on the benefits of information technology. It carries out strategic projects for its clients and focuses on 3 different areas:
1. Clinical trial management: Advice Pharma manages clinical trials in various therapeutic areas through an experienced team that collaborates closely with the sponsor.
2. Clinical research software: Advice Pharma has developed in-house electronic data capture (EDC) platforms and a clinical trial management system (CTMS) to manage clinical data more efficiently in compliance with Good Clinical Practice (GCP) guidelines.
3. Production of Digital Therapies
FULL CRO SERVICE – ONE-STOP SHOP
BIOREP AND ADVICE PHARMA GUARANTEE THE MANAGEMENT OF CLINICAL TRIALS THROUGH A PROPRIETARY SOFTWARE, COMBINED WITH THEIR OWN BIOBANK AND ANALYSIS LABORATORY THROUGH COMPREHENSIVE SAMPLE FLOW MANAGEMENT.
■ Study design
■ Drafting the research protocol
■ Clinical project management
■ Study start-up
■ Study Monitoring
■ Medical Monitoring
■ Regulatory affairs
■ Study report preparation
Clinical Data Management:
■ Design of paper CRF, development of eCRF and clinical database
■ Preparation of Data Validation Plan
■ Data Management and Data Cleaning activities
■ DCF/ Query Management
Real World Evidence:
■ Management of clinical data from external sources (laboratories, health records, images)
Decentralized clinical studies:
■ eConsent, ePRO, connected devices, remote visits and teleconsultation
Full logistic services:
■ Full logistic management of the study’s biological material
■ Sending of collection kits to national and international clinical trial collection centres
■ Collection of clinical trial biological samples
■ Complete traceability of the collection kits and biological samples through specific anonymised barcodes managed by the LIMS internal management system
■ Temperature-controlled storage of post-analysis clinical trial biological samples in its own biobank (from +4°C to -196°C)
■ Custom design for delivery of the clinical trial collection kit to the patient and its unique customised identification labels
■ Destruction or distribution of clinical trial biological samples at the end of the study
■ Cellular, molecular biology, microbiology and genetics laboratory services
■ Shipment of clinical trial biological samples to any external (national or international) testing laboratories
■ Support in the documentary drafting of the “Training Manual” for the centres involved in the clinical trial.