Our emphasis is on protocol-specific requirements and specifications during research. We offer services in the domain of:
- Pre-clinical
Our pre-clinical research services, handled by leaders in preclinical therapeutic and surgical services, include multi-technology research and laboratory facilities. They offer the industry an opportunity to benefit from some of the most advanced models developed by our top researchers. The expertise of our scientists in applying non-human primates to an array of advanced models is simply unparalleled.
- Bioavailability/Bioequivalence
Mudra Clincare, which is equipped to handle a range of early phase studies, allows its clients access to huge volunteer pools and superb turnaround times at efficient costs. It relies on its network of specialized clinical centers across the nation in taking up the intricate pharmacokinetic studies in patient populations. With SOP driven systems and processes and practices that are congruent with international practices, we can assure maximum data quality and security of volunteers. A dedicated Mudra project management team takes care of the quality and timelines at all phases of clinical studies.
- Medical Writing
We boast of an army of Medical Writers trained in Mudra Clincare values of delivering accurate and well-timed documents which are also cost-effective. The writers work close coordination with the teams of biostatistical, pharmacovigilance, project management, and clinical data management.
Once assigned to the client’s work, the medical writers mix up and become an integral part of the client’s team. This they achieve due to their flexibility to suit your scope. They possess the expertise essential to bring out the efficacy of the concerned company’s drug by guiding it through their clinical data. The documents undergo a thorough quality control review.
Our medical writers and other teams are backed by the knowledge and experience drawn extensively from clinical research consultants across the world and the pharmaceutical industry.
The services Mudra Clincare provides in medical writing are:
- Clinical and regulatory writing
- Medical writing consultancy
- Education material
- Scientific communications
- Clinical Trials
Each member who is part of Mudra Clincare research team has the experience of phase I to IV clinical trials, right from the stage of project initiation to final reporting. We offer detailed know how of clinical development and management that includes protocol preparation, feasibility and site selection, and application to authorities and ethics committees.
Add to this our data management and statistical services. Whether it is the full package or just a part of our services, we put in optimum efforts to comprehend your needs and provide you with services that are pertinent to your clinical trial or investigation.
- Biostatistics
The reputation of our statistical consultancy team, which consists of some of the most knowledgeable men in the industry, is the real foundation of Mudra Clincare. Biostatistical services form a key component of Mudra. From pre-clinical analysis to post-marketing support, our team is equipped to handle all research and development phases, across a wide array of therapeutic areas.
Our biostatisticians strive for excellence and device the best methods to tackle a situation and ensure accurate investigation and analysis without complicating the process. With the use of precise tools, we are able to establish the effectiveness of a drug and present comprehensive results. Our personalized approach helps us give our clients tailor made results that suit their needs. This results into enduring partnerships and sharing of biostatistics knowledge.
- Regulatory Affairs
Mudra Clincare presents the best Regulatory Affairs professionals who have been trained directly under world’s most competent regulatory authorities. Our team supports the clients in marketing drug safety regulations, document management, global marketing authorization applications, regulatory filings, variations and renewals, and meticulous marketing strategies.
Our regulatory expertise ensures that regulatory alternatives are taken into consideration at every step. This helps in getting product registration without neglecting the following areas:
- Regulatory Affairs
- Clinical Trial Applications and Product Registrations
- Regulatory Publishing
- Regulatory Writing
- Legal Representation
- Regulatory Affairs
- Pharmacovigilance
The pharmacovigilance solutions Mudra Clincare offers are risk minimization plans, clinical safety, and post-market surveillance. We have been blessed with a strong Medical Affairs team that comprises highly skilled clinical professionals and monitors every phase of the clients’ clinical development and post-marketing meticulously to analyzesafety profile of the products.
Our pharmacovigilance management involves laying out a detailed plan of each client’s safety processes. We also offer database and hosting services. These include collecting and managing safety data, database validation, and international reporting. We enable clients to access their safety data from a remote location any time.
Our Pharmacovigilance Services include:
- Safety Management Planning
- Clinical Protocol Safety Section Development
- Protocol review
- Case record form review / SAE form development
- Investigator Brochure review
- SAE collection, evaluation, classification, and reporting
- Processing of Serious Adverse Event or Unanticipated Adverse Device Effect reports Coding Review
- Periodic Safety Update Reports (PSURs), Annual Reports or End of Study Reports
- Medical case review
- Safety database development and maintenance
- Adverse event narratives and coding
- Regulatory reporting
- Setting upofGlobal Phamcovigilance Systems as per regulatory requirements.
- Reconciliation Services - Safety/Clinical Database.
- Regulatory Dictionary Coding - MedDRA, Sponsor Specific
- Remote access through a secure line
SITE MANAGEMENT SERVICES
- Site Feasibility and PI selection
Our biggest strength is our clinical trials network and inventory that helps us respond rapidly to a request for the feasibility of a clinical research project. We aid companies’ timely decision making by offering the crucial assistance in the go-no-go strategy. We perform an assessment of indication specific data to provide accurate analysis of enrolment, screen failure, and retention in a particular drug class or stage of research. Our alignment with the modern in-silico clinical trials gives us a competitive edge in the fast evolving research sector.
- Site personnel Training for ICH-GCP and other
Training and education are essential to help investigators, coordinators, and the other site staff grasp their precise responsibilities in a clinical trial. Our comprehensive site trainings consider protocol specific requirements, while stressing on the following points:
- ICH-GCP, Schedule Y, ICMR Code & other regulatory guidelines training along with ICF, Source documents, CRF, CT Documents, SMF, AE, Drug accountability, Roles & responsibilities.
- Protocol/ study specific training SAE reporting and safety management EDC Training CT Material and IVRS Central Laboratory Services.
- Site Co-ordination and Phase 0 to Phase IV study management
Our site management workforce and its uncanny capabilities is the result of a painstakingly created clinical knowledge base, which we constantly upgrade. This helps us take an innovative approach as well as keep us in tune with the needs of our clients, patients, and investigators. It also ensures compliance with the ICH-GCP.
You need an efficient and complete assistance on your study site for the investigators and site staff. A highly qualified Mudra Clincare clinical research coordinator, appointed exclusively for you, monitors compliance with FDA as well as with the local regulatory and ICH-GCP guidelines.
Besides clinical competency, a detailed operational knowledge of institutional infrastructure and research processes, our CRCs have habitually displayed strong personal ethics and people skills, which include patience and flexibility.
We constantly upgrade research sites according to study specific requirementsto expedite recruitment and study execution.
- Ensuring protocol compliance for all the events and the procedures.
- Attending Investigator meetings.
- Identifying potential eligible patients and short-listing of patients for chronic diseases
- Assisting investigator in obtaining informed consent.
- Scheduling patient visits as per protocol schedule of events.
- Patient registration and randomization through IVRS.
- Trial subject follow up
- Subject Retention Policies
- Coordinating laboratory sample collection/pick up schedules with local and central laboratory.
- To maintain the essential documents at the site.
- Queries resolution within the timeline
- Investigational product management, dispensing, temperature monitoring and accountability
- To maintain & document relevant communications with Sponsors/CRO i.e. meeting notes, letters and telephone calls.
- To assist the sponsors designated representative during site selection visit, site initiation visit and study close out visit.
- Preparation, attendance and follow-up of monitoring
- Preparation, attendance and follow-up of Audit
- Trial closeout: preparation, attendance and follow-up; forwarding the necessary information of closeout to clients.
Project Management
Project management involves managing resources in a planned manner to fulfill the objectives of a specific project. In clinical research, it is about understanding the value of Quality, Timelines, and Costs. Our strong project management team monitors these metrics for correct assessment of your project after taking your feedback on this.
The role of a project manager is critical in the success of a clinical trial. To manage the trial of your single clinical project, Mudra Clincare offers a dedicated and efficient team that oversees and manages each aspect of your clinical trial. Each team, which comprises highly experienced research associates, coordinators and assistants, is led by seasoned project managers.
While assisting clients in clinical operations, our project teams offer a wealth of knowledge and provide quality deliverables. The project management services Mudra offers are:
- Study start-up
- Feasibility Assessment, Investigator site selection & Project Milestones Planning
- Conducting & organizing Investigator meetings
- Investigator and site personnel training
- Provide input in development of essential trial documents (Protocol, ICF & CRF)
- Facilitate study activities and the provision of key deliverables
- Provide ongoing communication with team members and partners for study progress, procedures and policies
- Monitor study budgets and associated financial procedures and manages variances
- Management of clinical trial supplies & investigational product
- Oversee the study over its entire duration
- Quality Assurance/ Quality control
Our QA & QC systems ensure compliance of clinical trials’ data generation and documentation with the protocol, ICH GCP/ Schedule Y, and other regulations. System audits, retrospective audits, and in-process audits are conducted regularly by the QA/QC department to make sure Good Laboratory and Clinical Practices are adhered to, in addition to the compliance with the Standard Operating Procedures. Quality checks also verify the reliability of study data and guarantee corrective and preventive actions wherever necessary.
- Data Management
Mudra Clincare lines up industry’s most competent and well-trained men to form its Data Management and Biostatistics project team. Highly experienced in GCP and 21 CFR Part 11, our Data Management experts give you a complete package from Protocol Design to Database Lock without missing out on the standard operating procedures. They support our clients in integration and interpretation of raw data generated while navigating the complex areas of study design.
Our Data Management &Biostatistics services include:
- Data Management:
- Case Report Form (CRF) and Database design
- CRF review
- Data validation plan (DVP), Edit check Procedures, Data management plan (DMP) design
- Quality control of database.
- Query management system / Discrepancy management system.
- SAE data reconciliation.
- External data administration and integration.
- Medical coding.
- Database freezing and locking.
- Contract Monitoring
Mudra Clincare associates with sponsors to offer monitoring services. It has a team of highly-trained monitors – who have wide experience in various therapeutic areas -- dedicated to getting quality data by adhering to the standard operating procedures laid down by the sponsor.
- BA/BE study management
- Retrospective study management
We provide well equipped sites with:
- Patient pool with various indications
- All site specific requirements available
- Well trained CRC’s
- Experienced Investigator and Co-Investigator
- Separate documentation and storage Archival
- Patient Pool
- Investigator's qualification, trial experience and interest
- Papers published by the Investigator
- Hospital infrastructure and resources
- ICH/GCP trained staff availability
- Basic qualification of the site staff
- Investigator's and site's previous experience on clinical trial
- Ethics committee structure and timeline
- Accessibility to the site
- Central Laboratory services
- Patient load per month
- Standard of care treatment
- Types of medical equipment at site
- Profile of competing clinical trials at site
- EDC capabilities
- IRB Details including meeting times, frequency, makeup