regulatory affairs and clinical research management
Welcome to HAPLOS Consults, your premier partner in regulatory affairs, pharmacovigilance, and clinical research management services. Explore our comprehensive range of services and discover how we can empower your research endeavors.
WHO WE ARE
Haplos Consults Ltd is a beacon of excellence in the realm of regulatory affairs, drug safety, and clinical research management. Officially registered as a company in Uganda, our founders bring a wealth of expertise in regulatory affairs, pharmacovigilance, research ethics, and clinical research management. At the heart of our identity lies the word “HAPLOS,” a symbol of our commitment to providing undivided focus and sincerity in delivering services to our valued clients and partners.
What we offer
Regulatory Support
Simplify approvals, shield from hurdles. Ethical approval applications, Trial Master Files—start to finish.
ICH-GCP Training
Ensure safety, data integrity. Well-organized ICH-GCP and Human Subjects Protection training for research teams.
Pharmacovigilance
Detect, assess, prevent adverse effects. Timely reporting for patient safety—clinical studies, vaccines, medicines.
Clinical Research Monitoring
Prioritize research participants’ rights, safety, and well-being, ensure the integrity of clinical research data collected, and ensure adherence to approved protocols, SOPs, and regulatory and ethical guidelines.
Research Administration
Efficient project management. Budgets, compliance, staff recruitment and training, protocol and SOP reviews.
More Services
Explore More Services We Offer
why work with us
Future-Ready Support
Beyond archiving, we secure your research’s future with reliable and innovative solutions.
Safety-First Approach
Prioritize participant safety through our vigilant pharmacovigilance protocols.
Vigilant Monitoring
Proactive clinical oversight ensures participant well-being and ethical adherence.
Training for Triumph
Excel with tailored ICH-GCP training, fostering excellence in your research team.
FAQ - Your Questions Answered
Discover as you explore our Frequently Asked Questions (FAQ). Let the intricacies of your inquiries unfold, and allow our meticulously crafted answers to serve as your guide through the unparalleled advantages that define HAPLOS Consults.
What sets HAPLOS Consults apart in the field of research support?
At HAPLOS Consults, our unparalleled expertise in regulatory affairs, ethics, pharmacovigilance, and clinical trial monitoring distinguishes us. We simplify complex processes, ensuring a seamless and compliant journey for your research projects.
How does HAPLOS Consults navigate the regulatory landscape in Uganda and Africa?
Our experienced team acts as a shield for investigators, streamlining the ethical approval process. We handle the hassles of seeking approvals from Institutional Review Boards and Regulatory Authorities, supporting clients from the initial application to securing final approvals.
What is the significance of pharmacovigilance in the services offered by HAPLOS Consults?
Patient safety is our priority. Our qualified team specializes in detecting, assessing, and preventing adverse effects and drug reactions. We support our clients’ research projects by identifying and reporting Adverse Drug Reactions (ADRs) and ensuring the safety of trial medicines, vaccines, and medical devices in clinical studies.
How does HAPLOS Consults contribute to maintaining high research standards?
We provide highly specialized ICH-Good Clinical Practice and Human Subjects Protection training for research teams. Our training ensures the safety of participants and upholds the integrity and validity of collected data, contributing to maintaining the highest research standards.
What does the clinical trial monitoring service entail at HAPLOS Consults?
We offer both internal and external clinical monitoring services, prioritizing the safety, rights, and well-being of research participants. Our vigilance ensures adherence to approved research protocols, Standard Operating Procedures, and compliance with regulatory frameworks and international research ethics guidelines.
What comprehensive support does HAPLOS Consults offer in research administration?
From budget development and project fund management to protocol and SOP review, compliance assurance, and staff recruitment and training, we provide end-to-end research administration services. Our skilled human resource pool ensures the smooth execution of your research project from start to finish.
How does HAPLOS Consults handle translations and transcriptions for research studies?
We provide precise, localized, and timely translation and transcription services tailored to specific research requirements. Our team of experienced translators, who are native speakers, issues translation certificates for all completed work.
What is the importance of archival and storage services provided by HAPLOS Consults?
We support investigators in planning secure and reliable archival spaces, meeting specific regulatory frameworks’ minimum requirements for storing study patient documents and Trial Master Files.
How does HAPLOS Consults manage human sample shipment and support in Materials Transfer Agreements?
We guide and support our clients through the requirements and processes associated with transporting human samples for research purposes, obtaining Materials Transfer Agreements approvals, and sample shipment clearances. Our services ensure compliance and adherence to ethical standards and national guidelines for research involving human subjects.
