SERVICES

Rejuvendus clinical research eyes to create an atmosphere conducive to research by accepting all these challenges and to move hand in hand with its worthy and honorable clients.

Since our launch in 2006, we have seen unprecedented success throughout our service. As a leading clinical research solutions provider we provide our customers with an efficient, strategic approach, we strive to understand their requirements in order to deliver quality solutions, which will contribute to their success.

We at REJUVENDUS Clinical research believe, Clinical Research is a highly specialized field and requires specific training at specific levels to carry out various job functions. The need & complexity of the training at the level of individual stakeholder varies with individual job requirements. We have a professional ability to supply our brand of clinical research solutions in various sectors of Research industry.

Our abilities to expect the unexpected events would enable uninterrupted smooth conduction of trials.

Rejuvendus could be a partner to you and your organisation for a single service or full range of professional services.

Medical Writing

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Rejuvendus Clinical Research can undertake all types of medical writing services for Phase I- Phase IV studies.

Our Medical Writing services include all forms of:

-Regulatory document writing
-Marketing document writing
-Educational document writing

Rejuvendus Clinical Research creates clinical trial documents such as:

-Clinical trial protocol
-Investigator brochure
-Clinical study report
-Informed consent form
-Patient information sheet
-Annual reports
-Event summaries

We also write SOPs and develop scientific posters and manuscripts. We also have expertise in developing educational material as print or web-based learning systems and promotional material for our clients' sales and marketing efforts.

Documents are prepared in accordance with standard operating procedures and templates, and customized as per sponsor specifications with strictly following with US/EU/ICH guidelines and regulations.

Protocol Design

Protocol Design team of Rejuvendus Clinical Research designs product development programs in consultation with medical, biostatistics and regulatory experts.
We can assist in the planning of pre-clinical testing and clinical studies, and assist in the interpretation of study data. Clinical trials are designed with a view to provide a suitable fit within your overall development strategy for your product. Consultation with opinion leaders in the specific therapeutic area during the development of the protocols helps to maintain a practical approach to study assessments and ensures that new developments in the specific field are addressed.

Rejuvendus Clinical Research also offers consultation in product development and marketing strategy. Such consultation represents current industry practice, reflects "best practices", and assures compliance with all applicable regulatory requirements.

Marketing Material

RCRS also provides services for preparation of marketing material such as Product Monographs, Patient Information Leaflets, Product Information Brochures, Abstracts, Posters, Manuscripts, Scientific/ promotional texts, Press releases, Publications and Query Management-related documents.

Post-Marketing Surveillance

Rejuvendus Clinical Research offers a suite of post-marketing surveillance services to help sponsors collect, compare, process, track, and report adverse events.

Project Management

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REJUVENDUS Clinical Research considers its success in the success of Clients project. We work as a strategic partner to complement your team. Em a dedicated team of well experienced professionals, our project manager act as single point of contact in ensuring successful completion of your project. Each member of our project team is experienced and specialised enough to Put Right Ingredients of Success to your project.

All projects conducted by Rejuvendus Clinical Research, whether with a single service scope of work or a full-service global program; follow a common project management methodology that provides sponsors with a standardized approach to project management. This methodology provides each Project Manager with a set of standards and guidelines to manage projects in the most effective manner.

Through strong team structures, close communication, and detailed tracking and measurement, the Project Management group delivers consistent high quality services to our customers.
Our Project Managers are professionally trained with necessary skills to effectively manage the following important project management components:

-Sponsor relationships and communication
-Understanding specific requirements
-Effective Project planning
-Feasibility assessment
-Programming & scheduling
-Resource Planning and allocation
-Project Budgeting, Risk Planning and Analysis
-Project Communication
-Project tracking and status reporting
-Proactive issue identification and resolution

Projects vary based on size, complexity, therapeutic area and specific customer requirements.

Investigator Services

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Investigator Selection/ Database
Rejuvendus Clinical Research has an extensive database of investigators in several disease domains that consist of physicians with extensive clinical trial experience.

Investigator Meetings/ Coordination:

A successful investigator meeting helps to build stronger relationships with key target audiences and provides a platform to achieve great targets.
From scientific presentations to program management, meeting services, creative design and production, We aim to conduct effective dynamic meetings.

These interactive meetings are designed to be both informative and thought provoking, and enable investigators to develop a dialogue with sponsors on best practices for managing the study and gathering clinical trial data. The meetings also include training in key areas including trial protocol, current Good Clinical Practice and study-specific procedures.

Grant & Investigator Payments

Rejuvendus Clinical Research to efficiently create and manage Investigator contract and payment schedules those abide by local laws and appropriate agencies.
Rejuvendus Clinical Research also distributes and monitors Investigator grant and payment schedules for the Sponsor.

Sub Investigator's / Trained Doctors

A service Unique in itself, Rejuvendus Clinical Research is a Hub of Doctors Specialised in Clinical research Applications & Management. Our network of Trained Doctor's spread across the wide geographical regions of India. Our trained Professionals can be helpful to you all over India in your various needs for smooth conduction of clinical trials at various levels.

This service is especially helpful to Upcoming new CRO's & R'n'D Units.

Site Management Services

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Rejuvendus Clinical Research, is managed by a team of dedicated Doctor's & Clinical Research Professionals, We have an excellent network Trained Investigators spread across the wide geographical regions of India in variety of therapeutics areas. Our excellence in selection of Trial Sites / Investigators with a number of choices makes Trial Conduction smoother.

Site Selection:

The site selection process ensures that sites meet the necessary requirements of the trial prior to study site initiation.
Our selection process focus on the appropriate facilities and qualified support personnel at the specific site. All site registered in our database are independently audited and approved by us and all support staff at trial site are thoroughly trained in Good Clinical Practices as well as on trial procedures and requirements.

Patient recruitment:

The RCR team works closely with investigators to accelerate patient recruitment and ensure patient compliance. RCR also maintains a valuable dedicated online volunteer database.

Monitoring:

RCR provides Trial Monitoring services via central office-based and regional Clinical Research Associates. We make sure there is a smooth flow of active communication amongst project team members.
The Site Monitors are ICH-GCP trained and provided with trial specific and Sponsor's SOP training.
The Site Monitors are responsible for the efficient supervision of the site team, site team personnel training, the resources available at the site, and the timelines set for the study milestones at the site.

Pharmacovigilance

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Through a team of dedicated pharmacovigilance associates, Rejuvendus Clinical Research provides a comprehensive and reliable 'Safety Services Portfolio' which includes;

Study and Sponsor specific, dedicated Pharmacovigilance associates
24 x 7 receipt and processing of Serious Adverse Events (SAEs)
Capability to enter data directly into sponsor's safety database
Rapid medical & regulatory assessments of SAEs for reportability
Established pharmacovigilance follow up and management practices
Timely transmission of safety issues to sponsors, Regulatory Affairs & ECs / IRBs
Liaison between investigators and medical monitors at sponsor groups across varying regions and time zones . Coding of medical terms and medications using MedDRA & WHO-DD
Narrative writing
Designing & conducting Post Marketing Safety (Phase IV) studies & safety data collection
Site safety audits for compliance
Management of safety issues associated with Medical Devices & 'Product Technical (Quality) Complaints
Medical literature search for regulatory submission
Training Sponsors / Investigators in Safety reporting infrastructure & processes

Data Management:

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We at Rejuvendus focus on preparing clean database delivered on time Rejuvendus Clinical Research Clinical Data Management offers the full complement of Data Management services in clinical trials ranging from Phase I - Phase IV. Data Management Services are dedicated to the highest Quality, Excellence, and Client Satisfaction through Project Management, Communication, and Execution of studies.

-Database design and validation
-User access rights
-Data processing
-Query processing and resolution
-Coding and QC guidelines
-Data transfers and data handling instructions
-Global conventions.

Regulatory Affairs

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The Rejuvendus Clinical Research Regulatory Affairs team enables our clients to most efficiently develop their new drugs and to achieve timely and successful regulatory submissions.

We provide regulatory liaison services including agency interactions of all types such as responses to agency requests for information, planning and preparations for successful scientific advice development meetings, and preparation and submission of documentation for clinical trial and marketing applications that meet all international requirements.

We also provide strategic input, advice and services that are valuable to companies of all sizes.

Rejuvendus Clinical Research can provide input on documentation and agency interactions regarding exploratory INDs, fast track development, orphan drug classification, priority review, conditional approvals, and regulatory gap analysis of development plans, labeling negotiations, risk management plans, and Advisory Committee Meeting support.

Quality Assurance (QA)

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The hallmark of the Rejuvendus Clinical Research QA team is “Prevention is always better than correction”.

The following services are provided by the QA team:

-Clinical Investigator Site Audits
-Sponsor Audits
-Systems Audits
-Central Laboratory Audits
-Clinical Trial Supply Audits
-Adverse Event Reporting System Audits
-Computer Systems Validation Audits
-Database and Data Management audits
-GLP Audits

Audit observations are presented to sponsors by classifying them into minor, major and critical findings with specified timelines for reporting each of these classifications.

Our unique service is supported by over years of cumulative experience in Clinical research and its management.