Regulatory and Trial Start-up

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Premium support and expertise
in submission, follow-up and authorization procedures

Early Development (Ph. I-IIa), Ph. IIb-III, Ph. IV, NIS and IIT

Regulatory activities include:

  • VHP submissions
  • Local regulatory submissions

Start-up activities include:

  • Medical writing (from protocol to CSR, including preparation/adaptation of clinical documentation in local language)
  • Electronic Investigators Network in diverse therapeutic areas
  • Feasibility. Our experienced staff perform feasibility activities to assess site suitability and conformity
  • Site selection
  • Negotiations of contracts and budgets
  • Submissions to IEC/IRB and follow-up
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Study Management and Monitoring


Experienced project managers and CRAs to execute your trials
across Europe

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  • Staff training
  • Staff management
  • Act as SPoC (Single Point of Contact) for Sponsors
  • Ensure streamlined communication among parties
  • Project execution in compliance with all applicable requirements
  • Plan & track the patient recruitment
  • Oversee and coordinate monitoring activities
  • Ensure proper treatment of all study related data
  • Document management. The OPIS Documentation Unit provides centralized services for clinical trial documentation management and storage

An extensive network of experienced CRAs to cover 30 countries.
Remote monitoring activities, applicable for Field Monitoring and Risk Based Monitoring models.
Real-time, cost-effective overview of monitoring activities to help reduce the number of on-site visits.

Centralized Services

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Biometrics centre of excellence

A qualified centralized team of clinical IT, data management, statistical and Pharmacovigilance experts collaborating with you wherever you are.

OPIS CLINICAL.NET

Our biostatisticians and data managers play a pivotal role in the success of your clinical trial management. Statistical and data management expertise in combination with proprietary digital platforms, allows for planning, analysing and reporting of all phases of drug development.

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Data Management

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Integrity, transparency
and reliable clinical data

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With over 15 years of experience, OPIS provides advice and assistance to clients for choosing the most appropriate technology to collect and handle clinical data depending on study dimension, number of sites and therapeutic area.
The Data Management team interacts with the Clinical IT team to develop the electronic data capture (EDC) system and ensure Computer System Validation.

Our data management applies standardized and established processes from CRF design to database lock, including eCRF/database creation (CDISC or customized to company requirements), IVRS/IWRS set-up, edit check implementation and query management, status project and metrics reports, medical coding, reconciliation of serious adverse events and third party data handling.

The collected data is stored in our server for the entire period of the study and is backed-up daily. All our procedures act in accordance with ICH/GCP and local privacy regulations and our systems are FDA 21 CFR part 11 compliant.

SAS Programming


Qualified statistical SAS programmers manage clinical data and create tables, figures and data listings for reporting purposes. They also support our statisticians in statistical analysis modelling.

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Statistical Analysis and Consultancy


Biostatistical support throughout
your project’s life-cycle

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OPIS offers a wide range of statistical services. Our biostatisticians provide their support during the whole course of clinical trials:

  • Support for protocol development, including sample size estimation
  • Statistical analysis plan, including output shells and programming specifications
  • Interim analyses
  • Support for Steering Committees and Data Monitoring Committees
  • Support for regulatory submissions
  • Support for CSR and publications

Pharmacovigilance

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Eudravigilance-certified staff

The OPIS group offers a comprehensive and flexible suite of pharmacovigilance and safety monitoring services, from early development support through post-approval initiatives.

Our Eudravigilance-certified staff are fully qualified for handling SAE reporting and the submission of SUSARs/postmarketing safety reports through the Eudravigilance database. It is our objective to ensure the risk-benefit profile of products is monitored in order to maximise product potential whilst ensuring patient safety. Regular audits ensure compliance with regulatory and quality standards.

The OPIS Pharmacovigilance Unit also provides complete support for the management of:

  • Compassionate Use programs according to local requirements
  • Centralization of documentation relating to the management of endpoints in clinical trials
  • Management of customs clearance of drugs for clinical trials
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Quality Management and Project Control

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Going the extra mile for our Pharma, Biotech Sponsors. A personal touch in clinical trials. Promoting excellence

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YOU BENEFIT!

The Quality Management Unit is responsible for implementing OPIS’s quality assurance and enhancement policies and procedures, as well as those of Sponsors. By ensuring adherence to protocols, Good Clinical Practice (ICH-GCP) and local/international regulatory guidelines, our clinical quality assurance services help you ensure the integrity of your clinical trials. OPIS provides:

  • Clinical study document reviews
  • Consultancy for drafting and revising procedures and systems
  • Verification of Trial Master Files and Investigator’s Folders
  • Co-monitoring visits

Our Project Control Team makes sure that all stages of all activities related to your Clinical Research projects are strictly monitored. WE:

  • Ensure that requirements and timelines specified in contracts and/or Sponsor’s/OPIS SOPs are met
  • Provide extrapolation and data query tools for reporting to the Sponsor
  • Prevent issues relevant to timelines and contractual requirements
  • Facilitate information sharing
  • Interact with the Sponsor for supplying exports, reports, periodic status updates, etc., as required
  • Identify potential interfaces with Sponsor’s systems
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Study Design and Scientific Advice/ Clinical Development Strategy
If you are an investigator wanting to start a trial, please contact us. Our experts will assist you all the way.

Training
OPIS provides professional training for Clinical Monitors, Project Managers, Investigators, Hospital Data Managers and Medical Advisors. Our tailored training programmes are compliant with regulatory requirements. We offer cost-effective on-line courses with no need for on-site participation as well as in-house courses, workshops and practical simulations.

Investigator Meetings and Seminars
To develop strong, open avenues of communication with Investigators, OPIS offers meeting and seminar organisational support at any point during a clinical trial.

We help you reduce risk.

OPIS CLINICAL.NET


e-Clinical excellence
Integrated quality service
from a single source

  • Easy and user-friendly
  • No software needs to be installed
  • Access and sharing of data in real-time
  • Improved communication among all users
  • An online repository for storing all project-related documents

Digital management of clinical trials increases the general performance of a project’s progress and reduces overall error. The eClinical services developed by OPIS have been designed to streamline the execution of each project while safeguarding the validity and accuracy of each action taken by every study player.
Each eClinical module can operate as a standalone service or can be integrated into the CLINICAL.NET Study Portal to provide secure access to all modules through a single access point.

The fully customizable CLINICAL.NET Study Portal completely developed, maintained and supported by the Clinical IT Department in OPIS, collects, integrates, and reports all clinical data.
From project design to database lock, the proprietary software enables proactive study start-up management, direct electronic entry, information retrieval, and data analysis thus ensuring complete transparency across a project’s lifecycle.
To enhance security and compatibility, the Study Portal can be accessed without additional software or plug-ins. It is a web-based product based on a Three-Tier architecture powered by Microsoft NET Framework Technology and supports a variety of web browsers including Firefox, Chrome, Safari, and Internet Explorer.

Features:

  • Electronic Case Report Forms (eCRFs) in 5 different languages
  • Electronic Patient Reported Outcomes (ePROs)
  • Electronic Trial Master File (eTMF)
  • Integrated IVRS and IWRS procedure for centralized randomization
  • Embedded medical imaging capabilities (eImaging)
  • Electronic Learning platform (eLearning)
  • Clinical trial management
  • Protocol deviation assessment
  • Online medical terms coding (MedDRA and WHO)
  • Protocol amendment management
  • Study Drug management
  • Real-time reporting
  • Adaptive risk-based monitoring
  • Serious Adverse Event (SAE) data collection and notification
  • Online data validation

OPIS recognizes its responsibility to comply with ICH-GCP requirements for generating valid data. This responsibility extends to the use of computer systems for collecting, managing, and storing clinical and safety data as well as the integrity and ownership of the associated electronic records. The system has been validated in accordance with the regulatory requirements of FDA 21 CFR Part 11 regarding aspects of safety, traceability, availability and data integrity.

 

 

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