Protocol Writing:


Metrics Research personnel are experienced in Protocol writing that meets global standards. All the documents are prepared according to standard operating procedures and customized as per sponsor’s specifications. Our medical writers have rich experience in preparing protocols and integrated reports for Phase II-IV studies for local and multinational pharmaceutical companies. We could develop protocols, Investigator's Brochures, Case Report Forms, Patient consent documents, Patient diaries, Serious Adverse Event Reporting Forms, Integrated Summaries of Safety and Efficacy and Clinical study reports to the client in the required format.

Clinical Trial Operations:


Metrics Research Clinical Operations personnel are supported by a dedicated team that unable them to carefully track, review, compile and present clinical trial information from the investigator sites to the Sponsor at any point during the trial.

Investigator Site Selection:

The site profiling and qualification process of Metrics Research ensures that sites meet the necessary requirements of the trial prior to study site initiation. Metrics Research has an extensive database of investigators in several disease domains that consist of physicians with extensive clinical trial experience. These investigators have appropriate and adequate facilities and qualified support personnel. These investigators are audited and approved by Metrics Research and are thoroughly trained in Good Clinical Practice as well as on trial procedures and requirements.

Co-ordination of Investigator Meetings

Investigator meetings coordinated by METRICS RESEARCH is geared toward creating a dynamic environment for the interaction of individuals with a common purpose. 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 gathering clinical trial data. The meetings also include training in key areas including trial protocol, current Good Clinical Practice and study-specific procedures. From scientific presentations to program management, meeting services, creative design and production, Metrics Research aims to conduct meetings that are engaging, dynamic and effective.

Site Management

Metrics Research offers proactive modalities for management of diverse investigative sites including onsite visits to ensure necessary standards for conducting the study, training of site personnel, identifying and offering customized solutions to logistic issues faced at sites and coordinating resolution of non-compliance issues in a speedy manner. Throughout each clinical trial, the group works closely with sites to upgrade infrastructure to fulfill trial and current regulatory requirements. The Metrics Research team works closely with investigators to accelerate patient recruitment and ensure patient compliance. Metrics Research applies real-time site performance metrics that enhance the monitoring of the progress of studies at each site.

Site Managers:

Metrics Research also provides trained personnel on sites who required assistance due to their research work load. These individuals/site managers are extensively trained by Metrics Research on ICH/GCP guidelines and study protocol and procedures before allowing them to resume their Site Management services.

Grant & Investigator Payments:

Metrics Research’s familiarity with local legal environments allows creating Investigator contract and payment schedules that abide by local laws and include all appropriate agencies. Metrics Research also distributes and monitors Investigator grant and payment schedules for the Sponsor.

Clinical Trial Monitoring

METRICS RESEARCH provides Clinical Monitoring services via office-based Clinical Research Associates with a smooth flow of active communication amongst project team members. They are provided with trial specific and Sponsor SOP training (if required). The approach of each site monitor is that of a 'site manager'- he/ she is responsible for the efficient management of the site team, the resources available at the site and the timelines set for the study milestones at the site.

METRICS RESEARCH offers solutions driven by amalgamation of clinical expertise and technology that facilitate the collection of patient data in clinical trials. Leveraged by the infrastructure and high-speed connectivity systems, METRICS RESEARCH offers highly secure, state-of-the-art 24x7 services that permit high-volume data transfers.

METRICS RESEARCH is working towards developing capabilities in offering enterprise-wide e-commerce solutions in clinical drug development. In the immediate term, these e-business solutions will assure sponsors that high-quality patient experience data will be collected using real-time modalities, thereby maximizing the value of this information, so critical to successful new drug approvals. These solutions will be characterized by versatility, reliability, scalability, the ability to interface with existing clinical data management platforms at the client's end and collect patient data in compliance with stringent confidentiality and regulatory standards.

Clinical Trial Material Management

METRICS RESEARCH offers facilities and consultation for drug storage, inventory, temperature-controlled transport and early custom clearances for clinical trial supplies such as drugs, vaccines, other biologicals, devices, laboratory kits, equipment, and trial documents. These services are also compatible with the use of centralized randomization and blinding techniques.

The supplies customs-cleared and stored under customer-specified conditions with complete access control and disaster management and distribution is traced up to the delivery to site in accordance with METRICS RESEARCH SOPs. Tertiary storage areas designated for drugs and biologicals are maintained at room temperature, refrigerated and freezer temperatures with daily temperature monitoring and back-up generators. METRICS RESEARCH also arranges for return and/or destruction of expired, unused and damaged trial supplies under customer-specified conditions.

We have readily available storage for samples at the following temperatures: ambient, and refrigerated -20oC, -70oC and -80oC. Samples and materials that METRICS RESEARCH can store include genomic DNA, Plasma, serum, CSF, bone marrow, tissue specimens and biopsies.

METRICS RESEARCH offers secure off-site document and electronic data archival facilities and consultation for investigational sites, sponsors and IRBs on request. These archival facilities operate in accordance with SOPs that ensure complete access control and disaster management for business continuity. Each batch of project documents is maintained under stringent physical and logical security, temperature/ humidity level maintenance and environmental hazard control until such time as they are returned to the customer/ destroyed as per METRICS RESEARCH' SOPs. The documents that can be archived include CAT scans/MRIs, X-rays, ECGs and Case Report Forms.

Pharmacovigilance:

Metrics Research provides a 24-hour Immediately Reportable Adverse Event reporting service to ensure that patient safety issues are reported appropriately to the relevant authorities immediately. This real-time safety monitoring service is offered to biopharmaceutical sponsors for global multi-centric trials. The team also coordinates the completion of the necessary Reporting Forms by the investigational site. The team would act as a special liaison between investigators and sponsors, thus bridging the gap that varying time zones may entail. We could also provide worldwide coordination of clinical and post-marketing safety data collection, processing, and reporting.  

Data Management:

Biometrics:

METRICS RESEARCH offers Clinical Data Management services that meet global standards. A detailed Data Management Plan is prepared and a team comprising of Database Administrators, Clinical Data Coders, Document Administrators and Data Entry personnel is instituted prior to the entry of the first batch of patient data for each study. Database design and validation, data entry, query, coding and QC guidelines, data handling instructions and global rulings are finalized after appropriate investigator input and sponsor sign-off. Data can be exported in sponsor-specified formats. METRICS RESEARCH's biostatisticians work in tandem with programmers to prepare data listings, tables and graphs for export to the Medical Writing team.

With access to the high speed, high security communications infrastructure, METRICS RESEARCH plans to upgrade to electronic data capture tools and web-enabled clinical trial solutions. Sponsors would enjoy controlled and real-time access to study data on an 'as required' basis, for both project progress and decision support purposes.

Management Services

• Data Management Consulting
• Case Report Form Design, Printing, Distribution, Collection, and Analysis
• Data Validation Specifications
• Database Design
• Data Receipt, Logging, and Tracking
• Data Entry
• Query Generation, Updating, and Tracking
• Centralized Data Coding
• Data Quality Assurance
• Data Transfer
• Database Access Management
• Data Management Reporting
• Data Review Meeting

We have the capacity of creating scientific databases for all phases of the product development process, including integrated drug development databases, safety updates and medical records data management.

Biostatistics

• Protocol Preparation
• Prepare statistical aspects of clinical protocols including development of study design, sample size/statistical power determination, and formulation of statistical analysis section of protocols
• Describe both interim and final analysis strategies
• Consultation/Planning
• Consult on statistical problems
• Prepare for discussions with regulatory agencies
• Hold planning sessions with customers to interpret or clarify analyses
• Develop analysis plans for individual studies
• Report Preparation
• Prepare integrated clinical/statistical reports
• Design tables and graphics
• Write summary of all statistical methodologies and results

Quality Assurance


METRICS RESEARCH provides benchmarked auditing services in each area of clinical research ensuring accuracy, uniformity and integrity of data and diligence, timeliness, order and integrity of study conduct adhering to ICH-GCP guidelines. The QA Auditing group employs current global guidelines for conducting audits from study start-up to database lock for a given trial. Detailed, peer-reviewed audit reports are provided to clients and requisite training/logistic needs are identified and communicated to ensure requisite corrective action.
The group also offers the following:

• Clinical Investigator Site Audits
• Sponsor Audits
• Monitor Audits
• Central Study File audits
• Database and Data Management audits
• IRB Audits
• Phase I Trial Unit Assessments
• GLP / GMP Audits
• Mock FDA Bioresearch Monitoring Program Inspections
• Site Training and Educational Presentations
• SOP Development
• Pre Audit Preparation

Guidance in Corrective Action Plan preparation and implementation.