Protocol Writing:
Metrics Research personnel are experienced in protocol writing that meets global standards. All the documents are prepared according to standard operating procedures (SOPs) and customized according to sponsor 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 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 prescribed format.
Clinical Trial Operations:
Metrics Research’s clinical operations is supported by a dedicated team enabling it to carefully track, review, compile and present clinical trial generated information in a timely manner 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 a 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 exposure. 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.
Coordination of Investigator Meetings
Investigators meetings coordinated by METRICS RESEARCH are forums geared toward creating a dynamic and amicable environment for motivation and sharing questions about protocol, to engender team spirit, ‘putting a face behind a name’ for all individuals involved. These interactive meetings are designed to provide an informal setting yet be both informative and thought provoking enabling investigators and site staffs to develop a rapport and initiate a dialogue with sponsors on best practices for gathering clinical trial data. The meetings discuss current Good Clinical Practice (cGCP), safety and study-specific procedures among others.
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 studies at each site.
Site Managers:
Metrics Research also provides on site trainings or trained personnel to sites that require assistance for various reasons such as research workload or require a dedicated site coordinator. These individuals designated as site managers and coordinators are extensively trained by Metrics Research on ICH and GCP guidelines, study protocols and procedures before allowing them to assume their site management roles.
Grants and Investigator Payments:
Metrics Research ensures fair and consistent investigator payments thereby obviating compliance risks and reducing trial start-up time in the critical area of site enrollment. MR's experience with local laws and the regulatory environment enables it to shorten the negotiation cycle fostering rapid acceptance and active participation by investigators. Since the major contributor to the lengthy—and costly—delays in clinical studies is site contract and budget negotiations and approval MR accurately forecasts project costs and efficiently manages investigator budgets while providing trial managers and sponsors documentation and reviewable inputs showing fair payment value and reducing potential compliance issues
Clinical Trial Monitoring
METRICS RESEARCH offers clinical monitoring services through its project management team that coordinates planning of all monitoring services through a dedicated monitoring team comprised of clinical research associates. They are trained in monitoring skills as per ICH GCP monitoring guidelines and provided with study specific and sponsor SOP trainings (as needed). S/he is responsible for the efficient management of the site team, keeping them up to date with protocol specific requirements and new information ensuring that timelines and deadlines as set forth are attained.
METRICS RESEARCH offers optimal solutions by virtue of clinical expertise, sound clinical professional networks and liaison with regulatory department and ethics boards. Leveraged by good infrastructure and high-speed broadband capability, METRICS RESEARCH offers highly secure, state-of-the-art 24x7 services that permit high-volume and secure data transfers.
METRICS RESEARCH is working toward developing capabilities in offering enterprise driven e-commerce solutions in clinical drug development. In the immediate term, these e-business solutions will assure sponsors that high-quality patient data will be collected using real-time modalities, thereby maximizing the value of 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, biologicals (vaccines), 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 benefit from 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.