||Our mission is to
deliver best value to the benefit of patients,clients,employees and government
innovation,trust,speed,quality,global orientation,sound business
management and dedication to excellent service.
Cactus Communications (CACTUS) and Mene Research bring to you “best in class” regulatory writing, medical writing, QC auditing, transcription, translation, and English-language scientific editing services.
It’s All about QUALITY and PROFESSIONALISM
CACTUS offers high-quality regulatory medical writing and QC auditing to pharmaceutical, biotech, and device companies.
Smartsource your clinical research documentation to our team of regulatory experts.
Our regulatory writers have a thorough understanding of regulatory processes and guidelines. They will be able to work with your templates, style guides, document systems, and internal processes, within your timeline schedules and budget.
CACTUS clinical research documentation and QC auditing services include, but are not limited to, the following:
• Clinical study reports
• Summary and overview documents
• Investigator brochures
• PIP (Pediatric Investigational Plans)
• Patient narratives
• IMPD (Investigational Medicinal Product Dossier)
• Scientific editing, fact checking, formatting, copy editing
The medical writing team at CACTUS can also work with you to develop the documentation that you need throughout the life cycle of your product. CACTUS works with product development teams to help them effectively communicate their research.
• Congress abstracts and presentations
• Content, design, and layout of scientific posters
• Journal selection and submission support
• Literature searches
• Manuscript writing and editing
• Slide deck development
Mene Research dedicated team understands if quality sites are selected — those that meet recruitment goals with targeted number of patients on time, execute the study protocol successfully with qualified and motivated investigators and trial will likely finish on time and yield evaluable data. Choosing a quality site is essential to getting your trial done on time and correctly by reaching to targeted patient number.
We help sponsors identify the right study sites and right investigators by qualifying;
- Study specific qualifications of the site
- Prior experience with clinical trials
- Clinical and research reputation of PI’s
- Facilities, staffing, and equipment
- Appropriate patient population for enrollment
- Start of subject enrollment
- Duration of study
- Geographical localization
- Current and future workload to determine time availability
- Competing studies
Mene Research Regulatory Group efficiently manages and successfully executes all aspects of global start-up according to Sponsor specifications;
- Perform quality checks on submission documents and site essential documents;
- Interact with Authorities, CEC, EC, sites, and international associates;
- Prepare and approve and adopt to local requirements of informed consent forms;
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges; and
- Present during bid defenses, general capabilities meetings, and audits
- Ensure that the sections are complete, well written, and meet all relevant requirements. Develop excellent relationships with internal functional groups; contract manufacturing organizations, and partners.
- Facilitate device clinical trial and commercial application/registration by providing timely, relevant, targeted regulatory intelligence
- Develop and continuously maintain the regulatory knowledge management tool
Mene Research clinical operation group built by SMART monitors
S = Spokesperson
M = Manager
A = Auditor
R = Reporter
T = Trainer
Mene Research definitely aware that
Monitors are the main communication link between the sites and the sponsor
Their planning ahead to prevent potential problems, organizing available resources properly, motivating the site and controlling the situations constantly
They are the first level auditor
Their reports reflects the site activities
They are first level trainer for the sites
- Site Qualification
- Site Initiation Visit
- Interim Visit
- Site Close Out Visit
Mene SMO able to resourcing The Clinical Research Coordinators (CRC). In order to meet requirements of part-time, full time by sponsor
All Mene SMO CRCs are specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study according to Delegation Sheet filled prior to start up.
The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.
- Coordinates with Principal Investigator, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Local regulations and University and sponsoring agency policies and procedures.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with local regulations and University and sponsoring agency policies and procedures.
- Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by Authorities and sponsors.
- Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
- Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Conduct of Research
- Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, local required docs, etc.).
- Works with the PI to develop and implement recruitment strategies in accordance with CEC requirements and approvals.
- Conducts or participates in the informed consent process including interactions with the CEC and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
- Registers participants to the appropriate coordinating center (if multi-site study).
- Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
- Coordinates participant tests and procedures.
- Collects data as required by the protocol. Assures timely completion of Case Report Forms.
- Maintains study timelines.
- Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/ on Investigational Drug/Device Accountability.
- Retains all study records in accordance with sponsor requirements and procedures.
- Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
- Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
- Arranges secure storage of study documents that will be maintained according to local guidelines
Mene Research Project Management Group coordinates the operational aspects of ongoing clinical research organization projects to ensure that the clients’ goals of time, cost, and quality are met. The Project Manager serves as the primary contact with the client to ensure appropriate communications, project budget management, and meeting of timelines, of targets and of the budget.
Mene Research QA group operates independently and conducts internal compliance audits across all the departments for ensuring accuracy and efficiency of your trial.
Mene Research is also able to provide services externally with a wide experience of international pharma and CRO and MOH audits;
- Audit preparation
- Process assessments
- Risk assessment of audit and inspection findings, as well as evaluation of implications for overall project quality
- Development of Corrective and Preventive Actions (CAPA)
- Comprehensive training
- Facilitating Standard Operating Procedures (SOPs) and Guideline Development
Following the conduct of an audit, a detailed audit report is written with all of the observations made during the audit including practical recommendations for issue resolution and recommendations for preventive actions
Innovative clinical data collection system developed according to the SAAS model that sees software as a service, On demand, extremely user-friendly for physicians as well as for patients, and with a high degree of customization for our clients (no off-the-shelf software).
Custom-developed by senior medically trained per¬sonnel and specialized technical experts.
Providing you with products starting from a scientific point of view, not an IT standpoint, licenses to ensure you always use the latest available version and a modu-lar approach, BUT with dedicated specialized elements.
Adaptive to Fit Each Trial’s Specific Needs
Access to particular sites and data can be controlled down to a single
field based on role definition. MENE EDC allows for the same users to
have different roles and restrictions in each trial. As you add additional
trials in the future, access to all trials will remain through the single log
in. Workflow and role responsibilities can be configured to match your
processes and adapt to evolving research processes instead of having
to comply with rigid system requirements. Configurable page layouts
allow more data to be shown in a familiar format with less scrolling,
reducing errors and allowing for faster data entry and cleaning.
MENE EDC combines the innovation and experience of Mene Research in a way that investigators benefit most enjoying the advantage of one-click menus and easy navigation.
EDC is not a nightmare anymore thanks to MENE EDC unique easy to use platform and 7/24 service support.
No hidden charges
Mene Research , as a fair service provider always thinks and acts on behalf of its clients and in the beginning of each project a detailed proposal is discussed and concluded together. Clients never face hidden charges such as extra site visit fees etc and if any situation occurs which is out of the scope of the agreed contract this is always asked to Clients first.
Mene Research is working with very experienced statisticians in addition to clinical trials of Investigational medicinal products with different needs, local applications, FDA, EMA, medical device etc,
- CRF Design, Development & Printing
- CRF Tracking
- Database Design
- Data Entry
- Data Validation/Cleaning
- Query Resolution
- Electronic Data Handling
- Medical Dictionary Management
- Medical Coding
- SAE Reconciliation
- Quality Control
- Database Lock
- Protocol Input
- Sample Size Calculation
- Patient Randomizations
- Analysis Plan Development
- SAS Programming
- Data Listings
- Tables, Figures, Listing
- Analysis Reports
- DSMB Support
- Tailored Tracking Reports
- Web-Based Reports
Mene Research Expertise Team review and provide technical advice to prepare regulatory submissions
- MENE Research provides support to BioAvalability/BioEquivalence (BA/BE) Center which are willing to be inspected by Turkish Ministry of Health.(BA/BE Inspection Support)Many companies who look for dedicated staff and full support are already obtaining their approvals with the project management support from Mene Research
- Protocol writing
- General project resourcing and people management
- Investigator meeting planning
- Interfacing with Global teams and affiliate/regional hubs sharing intelligence information and trends
Mene Research expertise group provides tailor made training sessions to sponsors, research institutions,
- GCP training
- Advanced quality monitoring
- Site coordinator training
- CRA Training
Our service area also includes investigation and development of drug
molecules and medical devices. In clinical trials area, we are involved in the
management of early to late phase studies including the evaluation of the data
(feasibility, protocol writing, Ethics Committee and Ministry of Health dossier
preparation and submission, adverse event notification, data collection,
analysis and reporting) of these clinical trials. Following the investigation of
drug molecules and medical devices, MENE Research provides guidance at the next
level with the management of clinical trials process in compliance with national
legislation and international standards at a very rapid and high quality level,
MENE Research reduces the timeframe that a drug is being marketed to an optimal