OUR STORY
Why Choose IN RES CONSULTING?
Since October 2023 IN RES has been established in Mesagne (BR) as a business network by ClinOpsHub Srl and CD Pharma Group Srl.
The common goal is to create a new reality by combining expertise, experience, relations and customers of the two companies, mainly to support the incredible development in the Life Science sector which is currently taking place in the Salento area and throughout Puglia in general.
At the heart of this development are students, researchers and start-ups that revolve around increasingly performing and appealing universities even outside the regional borders.
Just as important is the objective to support any national or international company who is on the lookout for opportunities in innovative projects arising in this region.
INRES CONSULTING
Areas of action
IN RES is able to support the Target of Startups, Hospital Structures, Patient Associations, Study Groups and Scientific Societies and Private Companies at a consulting and operational level as Advisor for the strategic and operational definition of Quality, Training, Clinical and technological studies up to the defining of Guidelines and CCMs (integrated care pathways).
IN RES brings together a twenty-year experience of national and international projects complete with scientific reports, health stakeholder reports, and the whole array concerning the Pharmaceutical & Medical Device Industry and Healthcare Facilities.
WHAT WE DO
Our Services
Consulting
The Consulting unit is able to fully satisfy the different needs of the entire healthcare sector thanks to its extensive scientific knowledge and combined knowhow of the main clinical and administrative stakeholders, of the business logics of start-ups and of those involved in the pharma-related and medical device sector, as well as of the actors involved in corporate financing.
Contract Research Organization (C.R.O.)
IN RES shares the experience gained by the two CROs – CD Pharma Group and ClinOpsHub – in conducting Observational Studies, Diseases Registries and Phase I-IV Studies. Both the Italian CROs are regularly self-certified by the Italian pharmaceutical regulatory agency AIFA, which is a mandatory requirement to operate on the Italian territory.
With a team of about 40 highly motivated resources, we can guarantee timely management of clinical trials both in Italy and abroad.
The conduct of clinical trials in such a complex historical moment of relevant and important changes, makes the consolidation of a solid and effective relationship with the investigators an even more important aspect.
Guiding our clients from study-design to the choice of participating centres and through all the phases in between, represents our way of working.
This approach is facilitated by the use of innovative technologies to improve timeliness and to ensure elevated process quality and data accountability.
Innovation as an added value.
The technological innovation of recent years is also characterizing the Clinical Research world showcasing the introduction of new types of Clinical Studies with an evident impact on time and costs.
Digital Therapeutics, Decentralised Clinical Trials, Insilico Trials, are just some of the new possible solutions for Investigators that we have the capability to propose and follow up on operationally both directly and in partnership with exclusive players in the international scene.
Our Resources Innovation and new technologies are important, but our Human Resources are always paramount. Our resources follow a continuous and updated training plan that constantly combines effective processes and the computerization of all operating processes.
Our Resources Innovation and new technologies are important, but our Human Resources are always paramount. Our resources follow a continuous and updated training plan that constantly combines effective processes and the computerization of all operating processes.
- Immunology
- Cardiology
- Dermatology
- Hematology
- Gastroenterology
- Gynecology
- Infectious diseases
- Rare Diseases
- Laboratory medicine
- Neurology
- Oncology
- Pulmonology
- Psychiatry
- Rheumatology
- Urology
Our CROs are able to support all stages of a clinical trial in compliance with ICH-GCP/ISO 14155 Guidelines, applicable regulations and Standard Operating Procedures. We are happy to put our expertise at use in the management of interventional and observational clinical studies on study drugs or clinical investigations on medical devices and also on the coordination of all activities regarding disease registers.
In particular, we can support our customers in the following activities:
- Defining the synopsis
- Defining the synopsis
- Protocol writing
- Feasibility studies
- Clinical project management
- Trial start-up
- Monitoring
- Patient recruitment
- Medical Writing
- Investigator meetings
- GCP Audits
- Mock inspections
- Statistics and data management
- e-CRF customization
- Hosting and security functions
- Support in scientific publications
Technologies
One of the biggest challenges in clinical research today is managing all stages of a study, from its design, to executing the different tasks, to managing the budget. All in a timely manner and maintaining high quality standards.
In order to fully meet this need, we preferred to create our own Clinical Trial Management System (CTMS). The system has been expanded and completed with a validated eTMF section for the storage of essential documents.
We can offer customized eCRF solutions that meet the needs of our clients in the management of both profit and non-profit studies, within the framework of the most updated protocols in terms of Privacy and Security in data management.
We can offer customized eCRF solutions that meet the needs of our clients in the management of both profit and non-profit studies, within the framework of the most updated protocols in terms of Privacy and Security in data management.
Training
IN RES provides training courses for both graduate students and professionals in the clinical research field.
Below is an overview of our training courses:
Below is an overview of our training courses:
Fully compliant with the minimum theoretical requirements of the Italian DM 15/11/2011 for Clinical Research Associates, the 50 hour course allows students to obtain the basics concepts of the clinical research world. Indeed, the course gives them “the key” to open the first doors to the world of clinical research.
The Clinical Research Academy is a 30-hour annual training program created to allow clinical research professionals to fulfill the requirements of the Italian DM 15/11/2011.
In particular it offers continuous training and updates for those already working in the sector.
It’s a training package which responds to the needs of professionals working specifically in Phase 1 clinical studies (compliant to the requirements of the Italian Determina AIFA No.809/2015).
From emergency management, methodology of phase 1 clinical trials to Quality Assurance and Quality Control, the program offers the possibility to be constantly trained and updated on current international and national regulations.
Technology
One of the biggest challenges that clinical research professionals face is the management of all stages of a study, from the design to the execution of the different tasks, to the budget management in a timely manner and keeping quality standards high.
To meet this need, CD Pharma has chosen to build its own in-house Clinical Trial Management System (CTMS), designing and adapting it to its own needs and operating methodology.
The system has been expanded and completed with a validated eTMF section for the storage of essential documents.
Both systems have been developed following the indications and satisfying the needs of the Clinical Operations department and, consequently, creating an ad-hoc system that is tailored to meet the real management needs of the CRO.
Both CTMS and eTMF systems have been developed following the indications and satisfying the needs of the Clinical Operations department and, consequently, creating an ad-hoc system that is tailored to meet the real management needs of the CRO.
Both CTMS and eTMF systems have been developed following the indications and satisfying the needs of the Clinical Operations department and, consequently, creating an ad-hoc system that is tailored to meet the real management needs of the CRO.
Of fundamental importance is our experience of creation and customization of different eCRFs chosen to be more suitable to the type of study we are managing;
We have the possibility to use third-party proprietary eCRFs that we can customize according to the study, but we can also create eCRFs from scratch for non-profit systems.
IN RES, in addition to providing advanced and high-performance technologies for the conduct of Clinical Studies, Pre-clinical Studies and Disease Registers, can support public and private hospital technological structures at a consulting level, providing services of dimensioning, structuring and compliance and the necessary documentation for data collection and clinical study management (Computer System Validation).
Quality
IN RES, through its Quality Assurance Department, can support Sponsors, CROs and Trial Centres to comply with national legislation and international clinical trial ethical standards.
Our main activities are:
- drafting and revision of standard operating procedures (SOPs)
- staff training management
- CAPA management
- support during audits and inspections
To date, over 20 Italian Phase 1 Units are successfully supported by this department to ensure compliance with the requirements of the Italian regulatory Determina AIFA No. 809/2015 for the conduct of Phase 1 clinical studies in Italy.
IN RES can provide the following services in the field of Phase 1 Quality Assurance:
- Site Qualification Visits, to verify the site’s initial status in respect to the requirements described in the Determina AIFA No.809/2015
- On-site and remote QA support to ensure compliance with the quality requirements described in the Determina AIFA No. 809/2015. In particular, we provide qualified personnel according to Italian regulatory DM 15.11.2011, Quality Assurance Consultants and Auditor Consultants, who perform quality assurance and auditing activities at Phase 1 units.