- Phase 1 To 4 Clinical Trials
- Feasibility
- Medical Monitoring
- Project Management
- Regulatory Affairs
- Site Selection
- Vendor Management
- Clinical Safety Services
- Clinical Operations
- Investigator Site Selection
- Site Selection and Management
- Patient Recruitment & Retention
Clinical Trial Services in USA, India, Europe, & Australia
ProRelix Research is a growth-oriented CRO that provides drug development or clinical trial services from phase 1, phase 2, phase 3, and phase 4 with quality assurance and transparency. We execute services as per our standard SOPs in compliance with ICH-GCP principles, ethics, and well being of trial subjects.
We know the particulars of conducting phase 1, 2, 3, and 4 clinical trial services across the world, so we can make the complex less complicated, mainly for small pharmaceutical, medical device, herbal, nutraceutical, and biopharmaceutical companies that may be new to clinical trials. We have knowledgeable and experienced clinical trial professionals in the USA, India, and in multiple other countries across Europe, Australia, Africa which makes us uniquely positioned to help sponsors plan multi-country regulatory requirements.
Having team-provided clinical trial services for decades, we have determined strategies and processes to increase the speed of conduct and accessibility to new clinical trial sites. Our network with many investigational clinical trial sites, clinical research centers, patient groups, and medical consultants means we bring strong resources to bear in support of your clinical research projects.
Phase 1 Clinical Trial
Conducting phase 1 clinical trials is setting the best dose of a new drug with the fewest side effects on a small group of 15 to 20 trial subjects to check the safety of that drug. This dose-escalation study continues until the maximum dose has been attained as per the protocol requirement. If the drug is found to be safe, then it can be tested in phase 2. It includes single as well as multiple-dose administration. Here we are analyzing pharmacokinetic and pharmacodynamic parameters in strict regulations. This trial can be performed in single as well as multicenter also.
Phase 2 Clinical Trial
The aim to conduct a phase 2 clinical trial is to check the safety and efficacy of the drug with a particular disease and condition and monitoring common short-term side effects and risks associated with the drug. Here we are performing accurate monitoring in compliance with ICH-GCP principles, SOPs, and the applicable regulatory requirements to ensure the right, safety, and well-being of the trial subject.
Phase 3 Clinical Trial
The main purpose of conducting a phase 3 clinical trial is to obtain the safety and efficacy of the drug from phase 2 on a large group of people and compare it to commonly used treatment or standard drug or placebo. We are performing all the trials under well-qualified and experienced investigators. We conduct the trials using different study designs like a randomized trial, open-label/double-blinded, parallel, crossover trial, etc. which depend on the protocol requirement. We are successfully conducting such trials and meeting the requirements of the regulatory body for marketing approval.
Phase 4 Clinical Trial
Phase 4 clinical trials are conducted after the affirmative approval from US FDA, CDSCO, MHRA, EMA, and TGA for marketing purpose. The goal to perform this post-marketing surveillance trial is to obtain additional information about the risk and benefits resulting from the long-term usage of the drug on thousands of participants. Other purposes are also exploring new uses of the drug, drug-drug interactions, etc.
When you are outsourcing to ProRelix Research for conducting clinical trials, you are assured about all your services are of excellent quality with the given timeline.
(You can check our other range of services by clicking on respective pages)
Feasibility: (Assured Timely Enrollment)
ProRelix Research believes that a close working relationship with our investigators allows ProRelix Research to identify the geographic areas well known for the prevalence of the targeted indication. All regulatory requirements are then reviewed and timelines developed for each country to ensure that regulatory approvals will permit adherence to the project timelines. ProRelix Research then works directly with the most suitable sites in each geography. Sites are only considered if they have proven they can deliver a combination of acceptable enrollment, high subject retention, and data quality. Further, each site is requested to identify potential patients in advance of study startup, thus increasing the likelihood of meeting enrollment targets. A rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrollment rate and therefore successful planning of trial milestones is impossible, which in turn compromises the success of the trial. The more informed and better engineered clinical trials are, the more likely they will stay within budget and be on time. This is why we offer comprehensive feasibility studies as a component of full-service trials and also as a feasibility consulting offering. Our goal is to save you time and costs in the long run. At ProRelixResearch, we draw on our knowledge base of vast clinical research experience, site relationships, regulatory considerations, and industry catalysts to provide a level of insight that is not attainable using traditional feasibility assessments. While for some, feasibility assessments are synonymous with querying investigators and facilitating questionnaires, you can expect a more expansive and critical view of the clinical research environment from our feasibility analysis.
Our feasibility study services are customized to meet your specific clinical trial needs and include:
- Protocol review and design analysis
- Site profile analysis
- Site and patient motivation assessment
- Competitive landscape analysis
- Feasibility data analysis
- Screening and enrollment rate analysis
- Geographic optimization analysis
For help mitigating the risk and optimizing the success of your clinical trial, contact us today.
Medical Monitoring
ProRelix Research understands the need of many sponsors to have medically qualified clinical research experts leading various aspects of their clinical research.
The ProRelix Research team of medical monitors comprises physicians with many years of industry and appropriate therapeutic experience who are able to provide expert levels of oversight to areas including:
- Interaction and representation with Asia, Europe, Australia and USA Regulatory Agencies
- Clinical Investigation Plan design and writing
- Subject eligibility verification
- Clinical Investigation Plan deviations
- Serious adverse event review and reporting
Strategic Execution | Operational Mastery | Results with Impact
In the intricate landscape of clinical research, effective project management is not a luxury—it’s a necessity. From mitigating regulatory delays to managing stakeholder expectations and ensuring patient safety, every element of trial oversight hinges on coordination and foresight. Our clinical trial services (Phase I–IV) are structured to deliver just that.
How can we achieve this?
Project Managers are assigned to a project based on their experience and familiarity with the specific therapeutic area and indication. This prevents costly data errors and provides effective communication between the client, sites, CRAs, and the project team.
ProRelix Research makes training a priority and all our staff undertakes a specific and personalized training program. This means you can rely on the quality of our project management team assigned to your study.
You will find that the ProRelix Research project teams are characterized by their proactive approach to identifying potential issues and their provision of well-considered solutions. Our teams do not merely create a list of questions to ask our clients! Our organizational structure also allows direct communication with all levels of management and rapid response times meaning our senior management remains in close contact with your project.
The ProRelix Research project team consider themselves part of your team: together we agree on the best solution.
Adaptive Project Management
Using this approach, ProRelix Research recognizes that plans can be imperfect and uses data collected during the study to make streaming corrections. Adaptive management provides continuous optimization of day-to-day study practices analyzing and solving the operational issues that could negatively impact enrollment, monitoring, and query management — producing substantial cost and time savings. Real-time metrics track key enrollment indicators such as reasons for screen failures or effects of individual inclusion/exclusion criteria.
Adaptive management applied to the monitoring process, achieved by real-time site metrics, uses a team approach combining continuous site management and remote monitoring with needs-based allocation of site visits. Sites that are performing poorly (i.e. with low enrollment rate, or higher query rates, or more unresolved queries, or slower query resolution) receive greater attention. Moreover, best practices from well-performing sites are quickly identified and shared with non-performing sites. Allocating monitoring resources based on the number of remaining unmonitored fields prevents a lagging site from delaying closeout and database lock for the entire study.
Each aspect of the project is managed with a sophisticated and fully customizable Clinical Trial Management System (CTMS). Our systems provide a complete 360° view of the project, supporting accurate and timely decision-making by providing critical data in near real-time. The information is available to the client and the ProRelix Research team and permits all to interact with customizable data on every device via secure web-based access.
ProRelix Research has successfully managed complex projects in multiple therapeutic areas and is proud to have supported small to medium size companies. In addition, our specialized expertize in working with emerging pharma, biotech, and device companies helps us guide them through the clinical development process.
Our Project Managers collaborate with you from the start to ensure every aspect of a project is planned for and executed precisely. Our project management methodology incorporates standardized processes and metrics for reviewing project progression, risk assessment mitigation, and completion. Our goal is to complete every project on time and on budget while maintaining the high-quality product for which we are known.
Our project management team handles all requirements
Our full-service capabilities allow us to handle an entire program or the services specifically needed by our clients, from protocol strategy to regulatory submission and post-marketing. Our project management responsibilities include:
- Primary Liaison with Clients
- Team Management (Internal and External)
- Timeline Management
- Budget Management
- Project Status Reporting
- Risk Mitigation/Management
- Vendor Management
What we say is what we do
Perhaps our most important differentiator of all, we deliver what we promise. We are accessible – any time, any level, anyone. We offer you direct access to our executive, senior management, and project teams. Transparency in projects is a critical component of our partnership.
Regulatory Affairs
The key to fast regulatory approvals for clinical trials is based on understanding the ever-changing global and local regulatory landscape, combined with ongoing professional relationships with regulatory personals in each country.
ProRelix Research has both. Our regulatory team is constantly monitoring the regulatory environment of the global pharmaceutical and biotechnology industries, keeping track of changes in all local legislation, guidelines and regulations.
ProRelix Research Regulatory team consists of local staff with a deep understanding of that country’s regulatory requirements. Our staff will work alone or in concert with the sponsor’s Regulatory team. Together we will develop the strategic regulatory plan for the study, identify the best countries to be involved, and assist the sponsor in working with regulatory authorities and ethics committees, coordinating translations, and negotiating contracts with sites.
Site Selection
Site selection is a critical element of a successful clinical trial.
ProRelix Research site selection criteria are based on four guiding principles
- Predictability: the site should have a history of accurately predicting the enrollment of the required patients
- Enrollment: the site should have a history of enrolling the specified number of patients
- Retention: the staff and the procedures at the site should be professional and diligent enough to ensure proper patient retention
- Data Quality: the site should have the experience, staff, and methods in place to ensure quality data
ProRelix Research’s extensive experience with clinical trial units and hospitals has enabled us to develop close links to a large number of high-quality, motivated investigational sites with high recruitment potential. We also have a clear understanding of site capabilities to ensure that sites possess the equipment and skills to perform nonstandard clinical procedures. We select sites based on their history of meeting enrollment targets and consistent delivery of high-quality data.
During the feasibility stage, we work with the site team to identify prospective patients before study initiation, thereby giving clients the security of firm enrollment targets. From that first contact to the final database lock, our staff tightly manages the efforts and outcomes of every patient interaction, thus ensuring full enrollment and on-time execution.
When ProRelix Research is responsible for site selection, we guarantee full enrollment according to originally agreed timelines by using our Feasibility approach.
Vendor Management
ProRelix Research is experienced in selecting and managing third-party vendors, such as central laboratories, clinical supplies management providers, and IVRS. We take responsibility for the selection and management of these vendors, assuring compliance with quality and service deliverables.
Clinical Trial Supplies – With our carefully selected partners or those of our clients, ProRelix Research ensures efficient, effective and accountable distribution and subsequent return or destruction of investigational and any comparator devices.
ProRelix Research can also oversee packaging, labeling, and storage of products. Through our years of experience in clinical research, we are experts in the import and export requirements of authorities across the globe and provision of real-time resolution of issues.
Central Laboratories – ProRelix Research has extensive experience in working with providers of central laboratory services including biological sample laboratories, centralized diagnostic providers, central respiratory laboratories, and others.
Operational Supplies – Shipment and collection of a variety of other supplies is a central aspect to most clinical trials. This may include interactive response systems, study documentation, copies of images, and technical equipment, among others. ProRelix Research supports the storage and effective distribution of supplies for all studies.
Clinical Safety Services
Safety is imperative in clinical trials – new drugs and devices, no matter how innovative, cannot get to market unless proven to be safe for those who will use them.
Our Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology, and medical device companies to effectively track and manage their products’ benefits and risks throughout the product lifecycle. We can provide our clients with end-to-end clinical safety services from early phase through approval and post-marketing in 2 ways:
- As part of a full-service project
- As discrete, standalone offerings.
Experienced Staff Provides Clinical Safety Expertize
With expertize across multiple therapeutic areas, our safety staffs of highly trained professionals (including MDs, PharmDs, and RNs) is well versed in safety reporting practices and regulations. Our flexible infrastructure allows us to adapt to your specific safety needs, from case processing and medical evaluation to submission of safety data to regulatory authorities. Sponsors select the level of involvement in the clinical safety process suitable for your company and available resources.
Efficient Technology Enhances Your Study’s Performance
ProRelixResearch utilizes advanced software solutions for its safety database technology platform: Argus Safety and Argus Interchange. ProRelixResearch can offer Argus Safety as well as migrate safety data from legacy or discontinued systems.
We also utilize a validated, industry-accepted electronic gateway, an Interchange platform, in conjunction Safety with Argus. These technologies support safety surveillance for drugs, biologics, vaccines, and medical devices throughout the product’s lifecycle offering:
- State-of-the-art technology backbone with a clean interface, strong redundancy and an efficient configurable workflow to support evolving client needs – used for full-service projects
- Argus Safety database allows hosting for clients who do not have their own safety database and technology infrastructure
- Our system facilitates the secure submission of regulated data, such as individual expedited safety reports (ICSRs/SUSARs), to the FDA and health authorities in standardized ICH formats
In addition, such technology allows for the rapid exchange of safety data among marketing partners, affiliates, and/or vendors while ensuring the integrity of the data. You will have timely access to your data.
Safety Surveillance Services Are Tailored To Your Specific Needs And Include:
- Safety Surveillance support for standalone contracts as well as full service
- Product safety consulting (clinical and post-approval)
For a full overview of our suite of full-service and standalone safety surveillance services, contact us today to speak to our safety services experts so they can answer any questions you might have.
Clinical operations
Clinical operations are a critical component in all studies. From startup to close-out, our highly skilled clinical operations teams ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsors.
Our clinical trial managers provide leadership and operational expertize through collaborative planning, implementation, and execution. Clinical research associates work closely with your team on protocol and indication training, building strong site relationships, and ensuring site compliance. Finally, our wide network of clinical trial experts throughout India, and alliances with long-established partners in Europe, USA, and, South Africa, Australia, ensures global consistency, support, and a high standard of quality, meeting ICH-GCP guidelines, wherever in the world we manage your clinical trials.
Whether helping with an overload of work or designing a full-service clinical program, our experienced, knowledgeable team is ready to partner with you to develop a program customized to your needs.
Clinical operations services include:
- Worldwide feasibility studies
- Study startup including site identification, qualification, and selection
- Study document development
- Essential document collection and maintenance
- Translations
- Trial Master File set-up and maintenance
- Site monitoring and management
- Patient recruitment and retention strategies
- Clinical trial management system
- Training of clinical associates
- CRA management and quality control
- Audit preparation
- IRB/EC submissions
- Third-party vendor management
We’re your best partner. Our goal is to provide you with the services that best meet your needs, and responsible trial monitoring handled by experts. Tell us your challenges – we’ll help you determine your best course of action.
Our in-house Investigator Database enables review of site metrics including performance, speciality, location and population, ultimately enabling us to select the optimal study sites.
When selecting sites, whether from our database or not, our team take great care to ensure the sites chosen can provide the appropriate services in line the requirements for a particular study.
Our quality focused approach commands continuous innovation and flexibility both at investigative sites and in-house. The ProRelixResearch team create a customised site management programme for all studies from the simplest through to the most complex.
Our study co-ordinators have a clear focus on enabling a consolidated study duration through exceptional site performance, compliance and quality. Our holistic, flexible custom designed approach increases efficiency and promotes a balanced partnership between the clinical trial process and patient management.
We understand the critical importance to our clients of these site relationships, therefore we expend much time and effort to form lasting relationships right from study start up to study close out, working together with our study sites to meet enrolment targets and deadlines.
We add a personal touch by creating a unique identity for every study that will resonate with site staff and patients alike.
Meeting and exceeding patient recruitment goals can help to mitigate against delays in the project and ultimately enable us to achieve our study targets. Our team is able to identify recruitment challenges promptly so that we can take a proactive approach, resolving any issues quickly and efficiently to avoid any costly delays.
We create a patient-centric approach and deploy a myriad of recruitment methods and tools to overcome enrolment challenges. A combination of cutting edge media resources, dynamic patient education material and maintenance of effective communication with investigative site staff, all mitigate against the key barriers to delivering a study successfully
Clinical Trial Project Management Services
Strategic Execution | Operational Mastery | Results with Impact
In the intricate landscape of clinical research, effective project management is not a luxury—it’s a necessity. From mitigating regulatory delays to managing stakeholder expectations and ensuring patient safety, every element of trial oversight hinges on coordination and foresight. Our clinical trial services (Phase I–IV) are structured to deliver just that.
At ProRelix Research, project management isn’t merely a function—it’s a strategic asset. We align operational execution with regulatory expectations to ensure precise, timely, and high-quality outcomes. Our team works as a direct extension of your internal operations, delivering trials with rigor, speed, and strategic clarity.
Steering Clinical Excellence: The ProRelix Research Approach
Behind every successful clinical study is a skilled Clinical Project Manager (CPM). Our project leads are not just coordinators—they are therapeutic domain specialists, regional experts, and agile thinkers. These individuals drive:
- Operational Efficiency: Timelines, budgets, and deliverables are vigilantly managed.
- Strategic Alignment: Study designs are mapped to global regulatory trajectories.
- Risk Forecasting: Anticipating barriers before they materialize.
- Client Centricity: Acting as client advocates to ensure clarity and responsiveness.
Whether executing Phase 1 clinical trial services in India or coordinating global Phase 2 clinical trial management, our CPMs remain deeply embedded in every milestone.
Our Methodology: Precision Meets Agility
The ProRelix project management framework fuses SOP-driven discipline with flexible, sponsor-centric execution. Drawing inspiration from global leaders while preserving a boutique CRO’s responsiveness, we integrate:
- Feasibility-Driven Protocol Implementation
- Multifunctional Stakeholder Coordination
- Centralized Oversight Across Phases
- Risk-Based Monitoring (RBM)
This agile approach ensures our teams remain equally adept across diverse therapeutic areas, from oncology to rare diseases, and across study complexities—from Phase 3 clinical trial support for pharma companies to end-to-end Phase 4 post-marketing surveillance.
Personalized Leadership with Domain Expertise
Unlike conventional CROs, we assign project leads not by availability, but by therapeutic and regional suitability. Our team comprises professionals with substantial experience in:
- Neurology & Cardiometabolic Disorders
- Dermatology & Infectious Diseases
- Immunology & Orphan Indications
Such therapeutic congruence ensures nuanced communication, scientific alignment, and heightened operational accuracy. Our model mirrors the success of our CRO for early and late phase clinical trials engagements.
Real-Time Monitoring and Data-Informed Oversight
Our monitoring system evolves with your Clinical trials. It enables data-led decision-making through:
- Centralized Dashboards
- Resolution Time Heatmaps
- Inclusion/Exclusion Trends
- Data Entry Lag Indicators
- Protocol Deviation Surveillance
This ensures proactive site performance adjustments—preserving the scientific fidelity and regulatory compliance of your multinational clinical trial solutions.
Clear Communication. Measurable Accountability.
We preempt the common pitfall of communication breakdown by implementing structured plans from the outset. Sponsors benefit from:
- Dedicated SPOCs
- Dynamic Gantt and KPI Dashboards
- Weekly Status Reviews
- Quarterly Strategic Updates
- Senior Leadership Access
Whether you are conducting herbal clinical trials in India or biosimilar clinical trials for regulatory submissions, our commitment to transparency remains unwavering.
Technology That Drives Precision
Our integrated tech stack ensures traceable, audit-ready workflows. Through CTMS, eTMF, and EDC platforms, we offer:
- Unified Lifecycle Tracking
- Budget and Resource Analytics
- Centralized Document Access
- GxP-Compliant Audit Trails
- Real-Time KPI Insights
This robust digital backbone streamlines your clinical data management and supports synchronized global operations.
Full-Spectrum Project Ownership
From trial initiation to close-out, our scope encompasses:
- Client Liaison & Vendor Coordination
- Milestone Tracking & Site Activation
- Data Collection, Cleaning & Monitoring
- Budget Control & Regulatory Documentation
- Final Reporting & Closeout Compliance
We also provide extensive support for emerging sponsors, such as protocol design consultation, pharmacovigilance planning, and CSR preparation—ensuring lean teams gain full strategic leverage.
Why Choose ProRelix?
We’re not a high-volume, inflexible CRO. We are a clinical research organization in India with global reach and a partnership-first philosophy. Our differentiators include:
✅ Zero hidden scope changes
✅ Executive involvement throughout
✅ Therapeutic and regional project team alignment
✅ Flexible models for growing sponsors
✅ Transparent, no-surprises communication
Trusted Across Continents
Our record includes hundreds of trials executed under demanding timelines and regulatory scrutiny. Be it centralized or decentralized models, our teams deliver outcomes that consistently exceed benchmarks.
“ProRelix project managers feel like part of our internal team—they anticipate our needs and always keep us one step ahead.”
— Director, Clinical Operations, Mid-Size Biotech
Let’s Advance Research Together
Whether you’re scaling a precision medicine clinical trial or navigating multi-country clinical trial management, ProRelix Research brings the structure, strategy, and agility to drive your success.
