CLINICAL RESEARCH
Our clinical operation team systematically approaches day-to-day and strategic business issues, while project management team deals with planning, organizing, motivating, and controlling resources to achieve specific goals.
Our clinical trial operations and project management team have the experience and knowledge to ensure your study is supported and optimized to perform at the highest possible level every day.
Clinical trials are essential to discover new treatments for any disease as they aid in testing the safety and effectiveness of various drugs and devices. Since 2013, we at Oneiric Internationals, in line with the ethical and regulatory compliance required to undertake such trials, have been paving the way for clinical research in India. We offer clinical research services for various product lines, including Drugs, Medical Devices, and IVD, Biological, and Consumer Claims
Experience and Expertise in Regulatory Compliance: Trust Oneiric Services for Your Clinical Trial Needs; with a strong regulatory track record and numerous accreditations/approvals from regulatory agencies, Oneiric Internationals provides therapeutic, regulatory, and operational expertise to consistently solve your challenges.
Clinical Project Management:
Clinical project management entails coordinating all aspects of a clinical trial that significantly impact the research time and cost to develop a drug or device. It is an indispensable part of keeping all the activities on track by the efficient project manager. Oneiric’s Project Manager:
- Obliges as a chief resource and point of communication for the sponsor and project team.
- Delivers leadership and direction to the project team, comprising stipulations for time, quality, and cost of deliverables
- Utilizes global proficiencies, systems and processes to assure efficiency and accuracy throughout the project.
- Management framework to elevate the skills of functional leads and determination.
- Focus on the quality and efficiency of individual tasks.
- Follows risk management process, addressing potential complications to project delivery.
- Maintains a flexible, can-do approach to address issues innovatively and proactively.
Project Planning and execution
- Planning, organizing, and effective management facilitate transparency and controlling resources to achieve study goals.
- Detecting foreseeable problems/issues via monitoring the project’s critical path supported and optimized to perform all the project progress keeps things focused and moving forward at the highest possible level every day, thanks to dedicated expert Clinical Project Managers (CPMs).
Risk Management
Risk management is not only about avoiding or mitigating claims; it is a tool for improving quality in each possible step of clinical development.
- Demarcating risk assessment frequency, cross-functional team involvement, risk scoring based on impact and likelihood, proactive measures to decrease/eliminate the risk at impact or frequency level, pre-defined action plan if the risk becomes an issue, and most importantly, we ensure proper execution of the strategies.
- Risk Management Planning
- Risk Identification (General and study or product-specific)
- Categorize
- Select
- Implement
- Risk Management Planning
- Risk Identification (General and study or product-specific
- Risk Assessment
- Risk Control and Response Plan (Monitoring, Avoiding/alternating approach, Securing, Mitigation, and minimization)
- Risk Communication and Review
- Risk Sharing, Learning and Training
Vendor Management
The study team takes more than just objects to conduct a clinical trial. The best- fit approach of Oneiric Internationals brings the qualified vendors to the right place at the right time to support seamless trial execution.
We have both strategic and tactical levels of outsourcing activities based on the project requirement.
- Defining Requirements Specifications & Vendor selection criteria
- Vendor Identification
- Vendor Evaluation/Auditing
- Vendor Negotiation and Selection
Resource Management
One of the bottlenecks in research organizations is resource management, availability and access to adequate resources promptly and at an appropriate location is the golden motto of our resource management team. A clinical trial is an ocean full of multi-tasking, cross- functional involvement activities, and day-to-day-dynamic challenges; seamless working of all these domains requires a proficient workforce, vendors, and effective asset allocation.
- Work Breakdown Structure (WBS) for each project
- Appropriate project-specific training for the individuals involved.
- Timely availability of required assets (including but not limited to materials, devices, investigational interventions, ancillary supplies, etc.)
WORKING FLOW CHART
Step-I: Conceptual Phase
- Protocol Synopsis
- Scheduling of Activities
Step-II: Planning
- Protocol
- Clinical Model
- Site Selection
- MOP
- Case Report Form
- Clinical Trial Approval
- Contracts with Third Party
- Database Building
- Drug Labeling
Step-III: Implementation
- Subject Enrolment
- Drug Distribution
- Answering Protocols
- Attending Incident Calls
- SAEs
- Dosage Adjustments
- Premature Withdrawal
- Drug Disclosure
- Date Query Process
- Database Closure
Step-IV: Analysis Publication
- Conducting Analysis
- Submitting Abstract
- Submitting Manuscript
- Submitting CTR
- Post-HOC Analysis
Clinical Operation
Oneiric operation team is in the thick of action that kick-starts clinical trials. Carrying out clinical trials is cross-functional. Our operation team regularly communicates with each group to ensure they’re up-to-date on the relevant trial information. You can think of Clinical Operations as the crucial part within the spoke of a wheel.
Planning
We prioritize certain activities while planning the study operations and minimizing the anticipated risks at the initial level. Tracking the activities with the proposed plan plays a crucial role in study success within the committed timeline.
- Feasibility
- Site Selection
- Budget negotiation and Streamline with Investigator
- Execution and Tracking of Operation
Site Activation
Screening and Recruitment
Protocol Deviations
Regulatory/Audit Inspection Readiness
Study Timeline Management
Site Recruitment, Activation, and Motivation
Various Site Training
Site Engagement
As the name implies, site engagement keeps sites invested in the trial’s outcome in an effort to improve performance across the board. In short, it helps get the most out of the sites. We create a sense of ownership among them from the beginning of the study. We inspire them through friendly competition and equip the sites with the information and tools they need to make their life easier.
- Engagement makes easier to engage the site and sponsor
- Hasten stimulation
- Efficient communication and conduct of the study
- Inspection / Audit readiness
- Clinical Trial Payment
Patient Engagement
Being in this industry for so long, we know that patient engagement plays a vital role in clinical trial success, impacting everything from recruitment to advocacy.
- Patient enrolment (Recruitment and Retentions)
- Patient referral strategies (Direct-To-Patient-Recruitment) for rare disease
- Patient awareness and support
- Decentralized/Patient-centric approaches to ensure ease of participation and compliance
- Supporting Technological advancements (e-diaries, wearable devices, etc.)
Clinical Trial Monitoring Proficiency
The primary purpose of monitoring is to ensure that the rights, safety, and well-being of the trial subjects are protected and that the data coming out of the trial is accurate and credible.
Clinical trial monitoring requires data collection and analysis throughout a project to ensure validity, the integrity of the data, and the protection of human subjects
Our GCP trained Monitors help in:
- Mitigate Risk
- Systematize workflows to advance subject safety and compliance, Expands Study quality
- A blended approach of On-site & Remote Monitoring
- Uniform clinical data
- CRA allocation
- Pioneering approaches to stay off of regulatory change
Risk-Based Monitoring
RBM is the process through which we identify, assess, monitor, and mitigate the risks that could affect the quality of the study.
Identify latent threats: When commencing the study, we identify its critical elements. Deviation from these elements can jeopardize the entire development program. Hence we plan activities to mitigate this at each stage.
- Design a plan to monitor those activities
- Our robust monitoring plan will successfully implement risk mitigation, and we believe that risk communication plays a vital role during the monitoring
- Acclimate monitoring methodology as required
- Persistent risk assessment and allocation of experienced resources will help successfully implement processes.
