Clinical Trial Management

Our diverse and dynamic operational style, coupled with a pool of highly motivated in-house Clinical Research Associates, enables us to solve even most complicated issues and help you accomplish milestones.

End-To-End Support

As a contract research organisation (CRO), we are constantly improving to keep you one step ahead. We have a breadth of knowledge in many therapeutic areas and across all clinical development disciplines.

We provide Clinical Research Associates and Clinical Project Managers that work with you and your team on-site. Their awareness of legal standards, compliance, and regulations, as well as their passion, energy, and commitment, make them an outstanding choice to ensure your Clinical Development realizes its maximum potential.

Complete outsourcing or co-creation? That’s your choice. We tailor our approach to your needs.

We can support you every step of the way. Wether you need us to perform a medical unmet need analysis or elicitate experts or you need us to support reference development, we’re ready when you are.

To amplify your strategy, we can be involved in the co-creation of complete Business Plans, dealing with sponsors, and helping you prepare bids.

Trial Design

Our approach ensures accurate data transmission and minimizes changes to your clinical development strategy and associated delays.

While clinical development might be daunting, Cres’ expertise in patient outcomes enables you to enhance your clinical development efforts through a risk- and data-driven mindset. We begin our design process with access in mind.

Vendor Qualification

Regulators expect pharmaceutical companies to verify contracted vendors have adequate qualifications to complete their contracted work. These requirements can significantly impact your planning if not adequately managed. Cres’ professionals are at the ready to support you with a Quality check and investigate Accreditation.

Our clinical experts can also be involved early on to assists you in setting the right criteria for selection, bargaining, and contracting new vendors following our well-thought out workflow.

Project Management

Our Clinical Project Managers are in charge of the design and coordination of clinical trials encompassing drugs, medical devices, and diagnostics.

By maintaining a continual attention on the trial’s progress, we can trust and confidenly answer to any clinical queries, accomplish timelines, and surpass expectations.

Starting Up Clinical Studies Efficiently

Launching a clinical study is a critical task. Throughout clinical development, from patient recruitment through study completion, you must conduct a variety of complex and tightly regulated processes.

Increased pressure to minimize expenses and shorten timetables, combined with patients who are difficult to identify, poses a challenge. This is particularly true as trials grow globally, patient groups become more defined, and investigator locations become more remote. CRES  is prepared to support you through our Clinical Trial Project Magagement blueprint.

Study Co-Design

We collaborate with Investigators in Companies starting from the conception of a new clinical research project (interventional or observational) through evidence generation, financial plans, mediation with the sponsor or management of requests for institutional funds.

 

  • Analysis of the medical-scientific background
  • Elicitation of experts (surveys, focus groups, interviews)
  • Literature review (narrative, systematic, meta-analysis)
  • Drafting of the research protocol and Statistical Analysis Plan
  • Selection, revision, development and modification of e-COA (PRO, ObsRO, ClinRO)
  • CRF development
  • Financial plan
  • The conception of the project management, communication and coordination system of the teams involved

Start-Up

The CRES team supports the start-up phase of the study through the following activities:

 

  • Documentation collection
  • Preparation of the submission package (collection of essential documentation) and its translation into Italian
  • Management of the submission to the Italian Medicines Agency (AIFA)
  • Identification and selection of the most appropriate sites for conducting the study (feasibility)
  • Preparation and negotiation of contracts and related budgets, up to finalization and signature
  • Preparation of the Investigational Site File
  • Follow-up until the approval by the Ethics Committee and the signing of the financial conventions
  • Preparation of the CRF with reference vendor
  • Support for the preparation of the Investigator Brochure

From Initiation To Closeout

We make sure that the clinical site is ready to recruit patients in your clinical trial. We assure access to platforms and study systems, and completion of the relevant regulatory documentation, consent and approvals.

 Site initiation

  • Training on-site staff
  • Documentation GAP analysis
  • Alignment on target enrollment
  • Alignment on patient questionnaires, CRF, source documents

Interim Monitoring Visit

  • Review of informed consent
  • Source data review and verification
  • Control of SAEs and AEs
  • Drug accountability
  • Patient Safety Analysis
  • Control of the documentation and organization of the centre
  • Resolution of queries
  • Management and resolution of non-compliance

Closeout visit

  • Withdrawal of unused study material
  • Archiving of study documentation
  • Closing letter addressed to the Ethics Committee

Monitoring

Cres focuses on implementing effective risk mitigation from the outset of the study. The cornerstone of our multifunctional approach includes communication links across operations and emphasis on subject safety, high-quality data, and risk evaluation.

Risk-Based monitoring

  • Risk analysis in the design phase of the study
  • KPIs definition
  • Trends and outliers analysis for early identification of potential errors/risks
  • On-site & Remote Monitoring

Root cause analysis

CAPA

Biostatistics

Cres’ Biostatisticians are engaged from the start of your study. We ensure that both the sample size, hypotheses, and statistical models ensure the highest degree of confidence and that all of your study’s risks are recognized and managed from the start.

 

  • Build and manage the eCRF (including Hosting)
  • Data Cleaning & Project Management for eCRF
  • Data extraction
  • Statistical analysis

Medical Writing

Cres’ medical writers assist you in developing well-structured scientific documentation for clinical trials including:

  • Statistical Analysis Report
  • Manuscript Preparation
  • Regulatory documentation for national authorities
  • Local ethics committees
  • Posters for conferences and meetings

 

Clinical Research Academy

We see training as a crucial step to assist you attain your growth objectives. We believe that training is a vital aspect of improving clinical development.

Clinical Research Academy specializes in creating and delivering theoretical and practical training for professionals involved in clinical trials.

 

“Leave nothing to chance for your Clinical Trials. “

Start a conversation

Please feel free to contact us. We’re always glad to offer you our support,  discuss how to generate new evidences and disseminate results of modern-day advances in medical science. We will be glad to listen to you, and we will turn back to you with a tailored strategy, a detailed plan of activities, and a mindset to help you advance your goals.

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