About Us

  • CRPL serves as a SMO that facilitates seamless execution of clinical trials by connecting Principal Investigator(s) with Sponsor/CRO(s).
  • CRPL is currently based in Gujarat and has plans to expand its services to other territories in the near future.
  • CRPL provides a comprehensive suite of clinical trial processing and site management solutions to our clients.
  • The expert team at CRPL leads and supports our clients throughout all stages of the clinical trials, from the initial phase to the completion.

Investigator

  • Actively seeks out meaningful trials.
  • Requires assistance in conducting pre-trial and post-trial activities.
  • Prioritizes the medical care of study participants over trial logistics management.
  • Needs support in negotiating the trial budget based on the protocol schedule and logistics.

Sponsor

  • Searches for potential investigators.
  • Requires support in carrying out pre-trial and post-trial activities.
  • Focuses on ensuring the smooth and high-quality execution of clinical trials at the site level.
  • Requires 100% audit readiness at any given time.

Vision

To establish ourselves as a reliable ally for our clients, providing clinical research solutions while upholding the principles of ethics and bioethics.

Mission

To demonstrate skill and creativity in delivering solutions to our partners and clients, ensuring that clinical trials are conducted punctually and with the utmost quality.

Our Core Values

Why Clinardia is Preferred Partner?

Clinardia Research Pvt. Ltd. is dedicated to supporting the successful completion of a wide range of services, including Pharmacokinetic/Pharmacodynamics (PK/PD) and Phase Studies, Project Management (including Monitoring/Auditing and Regulatory Support), Research & Development support for Nutraceuticals, Herbals, Cosmetic & Medical Devices, Medical Writing & Dossier Submission, Data Management & Biostatistical Analysis, Pharmacovigilance, Training, and Translation of Research Documents.

As an organization, we serve sponsors with a network of over 100 investigators and possess valuable population data from various therapeutic areas. Our systematic project management ensures the accurate and compliant execution of Phase II, Phase III, and Phase IV Clinical Trials with a commitment to excellence.

We continually strive to identify and engage experts in the field of Clinical Research to meet the evolving needs of the healthcare industry and conduct cost-effective clinical studies in a timely and successful manner.

Time Management

At our company, we prioritize effective time management and initiate projects promptly, striving to achieve milestones within the scheduled timeframe.

Customer Focus

We foster long-lasting and collaborative relationships with our customers, working with them as partners in the clinical development of their products.

Quality

We are deeply committed to our work and aim for our name to be synonymous with providing high-quality data. Our determination is to set an example that the industry aspires to follow.

Adherence to Timelines

Time is of utmost importance to us, and we strictly adhere to our commitments, following a disciplined approach to meeting timelines.

10
Years of Experience

Our Team

Our primary team consists of highly skilled and knowledgeable clinical research experts with extensive experience in conducting phase I-IV clinical trials for both Indian and international Sponsors/CROs. The Clinardia Research Pvt. Ltd. team collectively possesses over 10 years of experience in the field of Clinical Research, enabling us to strive for service excellence.

Site Network & Site Management

We recognize the crucial role that investigator and site selection plays in the success of clinical trials. It directly influences factors such as enrollment, patient retention, data integrity, study timelines, and cost.

CRPL offers sites access to investigators and site staff who not only possess the necessary qualifications and experience, but also demonstrate a strong track record of patient enrollment and commitment to maintaining quality. They are genuinely passionate about the field of clinical trials.

At CRPL, our passionate and dedicated team consistently achieves results, regardless of the challenges faced. Our site management team fosters close relationships with patients, ensuring high patient retention rates. This dedication helps to safeguard the study’s objectives and endpoints by minimizing missed visits, early withdrawals, and loss to follow-up.

Key Differentiators:

Study Startup & Patient Recruitment: Investigator & Patient Database:

Clinardia Research Pvt. Ltd. possesses a unique network of investigators and patients actively seeking new trial opportunities. We harness this exclusive resource to identify sites that are the perfect fit for each protocol, maximizing the chances of success.

As a result, we ensure that study startup timelines are minimized, accelerating recruitment by tapping into a pre-identified pool of willing patients. We maintain a patient-centric approach and recognize that patients are the driving force behind all clinical trial activities at the site.

Our Services

Our Clinical Trial Monitoring services encompass the following:

  • Project management
  • Monitoring compliance with regulatory requirements and protocols
  • Facilitating the acquisition of local Ethics Committee/Institutional Review Board (EC/IRB) approvals
  • Managing the inventory of supplies
  • Offering input on clinical development plans and protocol design
  • Providing training to Clinical Trials staff and investigators
  • Advising the protocol team on safety oversight
  • Maintaining timely communication with the sponsor and relevant authorities
  • Evaluating adverse events/Serious Adverse Events (SAEs) and reviewing safety reports

Clinardia Research Pvt. Ltd. delivers data management services with a strong commitment to following established operating procedures and implementing rigorous quality standards and processes, particularly for large and intricate clinical programs. Our systems fully comply with relevant regulations and guidelines governing data management.

Our medical writing services offer a comprehensive range of high-quality documents to support every phase of the product life cycle, starting from pre-clinical development and extending through post-marketing activities.

At Clinardia Research Pvt. Ltd., our biostatistics services are extensive and can be customized to align with the specific requirements of our clients. Our services cover the entire spectrum of pre-analysis, analysis, and post-analysis activities

CRPL provides all-encompassing pharmacovigilance and safety monitoring services, supporting projects from the early stages of development to post-approval initiatives. We have a team of experienced and highly skilled medical professionals who possess firsthand knowledge of regulatory requirements in this field.

CRPL provides Quality Assurance services in the domain of Good Clinical Practice (GCP), aligning with relevant GxP regulations. Our quality assurance auditors possess extensive knowledge of local, national, and international regulations, standards, and guidelines.

CRPL offers specialized services to manage local regulatory matters with the regulatory authorities, ensuring client expectations are met in a realistic and transparent manner. We possess extensive knowledge of the clinical development requirements set forth by regulatory authorities such as the US FDA, EMEA, DCGI, and others.

CRPL offers comprehensive management services for all phases of clinical research projects. Our dedicated Project Manager assumes various crucial roles, including:

  • Serving as the primary resource and communication point for the client and project team.
  • Providing leadership and guidance to the team.
  • Ensuring the studies adhere to the designated schedule.
  • Managing project budgets.
  • Selecting and coordinating vendors.
  • Reporting on project results.
  • Enforcing compliance with relevant regulations and guidelines.

Qualities

Data Security & Business Continuity

We strictly adhere to information security and recovery policies in compliance with relevant regulatory requirements to ensure the safety and continuity of data.

Data Quality

We maintain high data quality standards through internal quality control processes, following our standard operating procedures (SOPs) and industry best practices.

Validated
Infrastructure

Our operations take place in a fully validated environment, with systems that undergo IQ/OQ/PQ validation and comply with 21CFR Part 11 regulations.

Personalized Care/
Customized Solution

We offer personalized service through a dedicated project coordinator who serves as a single point of contact, providing customized solutions tailored to the unique needs of our clients.

Technical Expertise

Our team possesses extensive expertise through exposure to a wide range of projects with varying levels of complexity.

Qualified Team

We implement a consistent and rigorous company-wide training program to ensure our teams are well-prepared before they begin working on your project.

Time/Price Advantage

With the involvement of dedicated team members, we are able to expedite project completion, resulting in faster turnaround times. Our efficient business model also leads to significant cost savings for our clients.