MEDICAL WRITING SERVICES
Metrics Research has an experienced medical writing team, fully capable of writing clinical research related documents and papers for publications such as the following:
- Investigator’s brochures
- Study protocols,
- Patient information sheets/ case report forms,
- Patient questionnaires/ diaries
- Safety reporting forms
- Case report forms
- Interim analysis reports on safety and efficacy
- Clinical study reports,
and other study related documents as per SOPs, sponsor requirements, and global standards.
Our medical writers have rich experience in preparing protocols and integrated reports for Phase II-IV studies and Bioequivalence/Bioavailability studies for national and multinational sponsors.
DRUG SAFETY AND PHARMACOVIGILANCE
Metrics Research provides a 24-hours adverse event reporting service on an ongoing basis to ensure patient safety issues are reported appropriately to the sponsor and relevant health and ethical authorities. This real-time drug safety monitoring services is offered to biopharmaceutical sponsors for global multicenter trials. The PhV team also coordinates the the necessary reporting by the investigational sites. Our team acts as a liaison between investigators and sponsors, thus bridging the gap that varying time zones may entail. We can facilitate coordination of clinical and post-marketing safety data collection, processing, and reporting for local and global clients.
CLINICAL AUDIT SERVICES AND 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 any 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.
Our audit group also offers the following services:
- Clinical Investigator Site Audits
- Sponsor Audits
- Monitor Audits
- Central Study File audits
- Database and Data Management audits
- IRB Audits
- GLP / GMP Audits
- Site Training and Educational Presentations
- SOP Development
- Pre Audit Preparation
Guidance in preparation and implementation of correction plan is also provided to clients.
CLINICAL DATA MANAGEMENT
Metrics Research offers optimal solutions leveraged by good infrastructure and high-speed broadband capability, highly secure, state-of-the-art 24×7 services that permit high-volume and secure data transfers.
Metrics Research offers Clinical Data Management services that meet global standards. An effective 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.
Data management consultation may include;
- 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
BIOSTATISTICS AND STATISTICAL PROGRAMMING
We have the capacity of creating scientific databases for all phases of the drug development process, including integrated drug development databases, safety updates and medical records data management and statistical analysis and interpretation of the data.
- 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 on statistical problems
- Hold planning sessions with customers to interpret and clarify analysis
- Develop analytical plans for individual studies
- Prepare integrated clinical/statistical reports
- Design tables and graphs
- Summarization of statistical methodologies and results
CLINICAL TRIAL MATERIAL MANAGEMENT
Metrics Research offers facilities for drug storage, inventory management, temperature controlled transportation and early custom clearances for clinical trial material (CTM) such as drugs, biologicals, devices, laboratory kits, equipments, and trial documents. These services can also be provided along with centralized control, randomization and blinding techniques.
The CTM is stored under customer-specified conditions in controlled access area and distribution is done as per client’s requirements or Metrics Research SOPs with complete traceability record. 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 material in accordance with customer-specified conditions.
We have well defined storage areas for samples at ambient, refrigerated -20oC, -70oC and -80oC temperatures. Metrics Research can store and transport biological samples (plasma samples, serum samples, CSF, bone marrow samples, tissue specimens and biopsies) for proteomic, genomic and biological marker analysis.
MEDICAL TRANSLATION SERVICES
Metrics Research can offer excellent translating services through its associates at academic institutes ensuring a fast turnaround time for clinical trial documents, ranging from patient information consent forms to Investigator’s Brochures. The translation process is coordinated by experienced personnel with medical/ pharmacology expertise to ensure accuracy and consistency in content and style. Translation services are available in all major languages of Pakistan as well as foreign languages such as French, German, Spanish and Chinese via collaborative partners in a time – and cost effective manner.