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What We Do
Clinical Research
Clinical trials have grown in scope and complexity, necessitating proper supervision to ensure success. However, due to clinical research’s various intricacies and criticalities, this is not an easy process. Our team is well-versed in best industry practices and keen to attain operational perfection by delivering high-quality results on time. MSI clinical site monitoring services are provided using dedicated site solutions across Nigeria and Sub-Sahara African region in all time zones. If necessary, monitoring personnel can be trained according to the sponsor’s procedure and on-site seven days after the first visit.
We are committed to keeping the clinical trial processes on track while maintaining expected quality by supporting all the sponsor’s criteria for eligibility review and exact randomization of a subject.
Lastly, we are committed to a documentation system that ensures quality documentation according to rules and is consistent with ICH-GCP and other standard operating procedures. We offer a well-planned and robust clinical trial management framework compliant with 21 CFR Part 11 and can strengthen archive tracking at the global level.
Clinical Operations
Medical Writing, Medical and regulatory documentation are critical to clinical research’s effectiveness. All regulatory standards must be met for the documents to be valid. Our stringent quality control procedures ensure that all regulatory requirements are met, resulting in high-quality material for our clients. We provide a full range of medical writing services and customize them to meet clients’ specific needs. Our medical writers can work on individual documents and large-scale documents to develop and maintain quality standards of documents that meet various regulatory authorities’ requirements.
Clinical Data Management
Electronic data capture (EDC) is utilized to digitally record various clinical data of the participants at different stages of a clinical study. Our EDC is a one-stop shop for all types of patient/subject information. The EDC program allows for quick database access, extraction, and integration. It is protected in the cloud, and data can be sent from the client to the server utilizing protocols. Our “Advanced Electronic Data Capture (EDC)” features, which we developed in-house, enable us to streamline the entire clinical study process, from study design to data capture and management, with few errors.
Our core objective as a data-driven CRO is to provide our valued clients with high-quality, trustworthy data. Our unwavering commitment to accelerating the clinical process by providing excellent data aids us in building confidence and establishing a long-term partnership. MSI’s data management team comprises highly skilled and devoted data managers who are familiar with ICH-GCP and GCDMP, as well as a wide range of therapeutic areas, and can efficiently handle clinical trial data across all phases and geographies. Not only does our team excel at data collection, management, and analysis, but it also excels at identifying and resolving data discrepancies to maintain data quality. Our staff is backed up by industry veterans, whose extensive operational and management experience drives us to provide outstanding data management solutions to all of our clients.
Regulatory Affairs
Our interdisciplinary, skilled, and supportive regulatory team members are flexible enough to handle all regulatory responsibilities, including assisting biopharmaceuticals seeking marketing authorization of new products in Nigeria and other African countries by helping in compiling and writing any specific module or the full technical document.
In addition, we support businesses in setting up their document management and technical writing systems. Our regulatory affairs team ensures that regulatory compliant paperwork is prepared, submitted, and approved for each clinical research stage. We work closely with the client’s team to assure quality, worldwide compliance, consistency, and support at every level.
Our Global Regulatory Services Include:
- Pricing and Market Authorization Approval
- Regulatory support for clinical trials, Facility Inspections
- Product information (SPC, PILs) communication
- Pre-IND and Pre-NDA meeting with NAFDAC and other regulatory agencies in Africa
- Providing the clearances and issue resolutions
- Drug Product Services: NDA, ANDA
- Writing and compilation of INDs, NDAs, ANDAs, and supplements
- Electronic Clinical Trial Protocol and Documentation submission to NAFDAC
- Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
- Case Report Forms (CRFs)
- Product Life Cycle Management
Drug Safety & Pharmacovigilance
At MSI, We recognize the importance of patient safety, drug safety, and pharmacovigilance in clinical trials and post-marketing activities. We provide drug safety and pharmacovigilance consulting services at all stages of drug/device development, from preclinical to clinical to post-market. Our team of seasoned drug safety and pharmacovigilance experts assess and manage product safety issues.
We provide complete drug safety and pharmacovigilance solutions. Our worldwide dispersed staff is dedicated to providing accurate, compliant, and effective pharmacovigilance services before and after approval. We offer a wide range of safety and risk management services, including
- Patient experience state of the art call centers
- Case processing and quality control services
- Safety reporting, analysis, and interpretations
- Safety signal detection
- Risk administration and management
- Counseling for pre-advertise improvement and post-marketing exercises
Our pharmacovigilance experts work tirelessly to deliver all reports within sponsor or regulatory timelines and the budget. Our high-quality results are exceptional to our clients, allowing them to approve products sooner. MSI invested in safety databases like Oracle Argus, Aris Global, and Oracle EMPIRICA for improving safety data capture, processing, analyzing, reporting, and effective signal detection and management.
Hospital Management Services
MSI provides healthcare facility management to the government on public-private partnerships and private health institutions. Our innovative and strategic lean management approach has redefined the healthcare landscape and brought succor to healthcare payers and providers who faced unprecedented changes, mounting pressures due to advanced technology, and growing customer expectations.
MSI has served the healthcare industry in Nigeria since it was established, supporting both Public and Private health institutions to develop policies that improve healthcare delivery systems. Our agile approach to the industry’s complex challenges has helped healthcare organizations modernize how they do business to ensure business continuity and sustainability.
Healthcare Business Process Improvement
Our team guides organizations seeking a competitive advantage and lean transformation through the complex world of digital transformation in the Healthcare industry by providing assistance to address their aspiration to improve patient care quality, efficiency, and coordination. We support healthcare stakeholders in becoming highly efficient at saving and improving people’s lives, delivering a seamless patient experience, and ensuring value-based care with innovative solutions.
MSI has deep expertise in digitalizing every aspect of the healthcare value chain to grow revenue by implementing lean transformation aligned with the organization’s desired success by leveraging our expertise, network, technology, and data-driven insights. Our integrated system and software allow healthcare organizations to track care across many settings, with all the information needed at their fingertips. Whether it’s an EHR, LIS, RIS, claim management, or revenue cycle management, seamless integration of custom applications with installed third-party systems is essential.
Workforce and Recruitment Services
MSI offers various staffing and recruitment services, ranging from contingency recruitment to preferred supplier appointments (SSPM) (Search, Selection, and Payroll Management). In ad hoc vacancies and high-volume projects, we assist candidates in obtaining contract, provisional, and full-time positions.
We understand that people are an essential factor in a company’s growth and success. We are also aware that we have a team of highly talented biopharma and healthcare recruiting specialists whose expertise is used in our specialized recruitment areas – life sciences, healthcare, and managed care industry. Our staffing solutions include selecting, screening, engaging, and managing contingent workers, independent consultants, full-time or direct hires, and functional-service solutions. Such services enable higher productivity and greater efficiency while improving competitiveness to permit our clients to be more agile and resilient.
Do not hesitate to reach out to us
Set up your next visit with one of our dedicated physicians. Got questions? Please call and ask and we will give you the answers you need. Call us today!