Clinical services

Project Management

In order for your clinical trial to be successful, it’s necessary you will need a professional project administrator. We have the best project managers in the field, with frequent up to date training to ensure your trials are fast and efficient. When working with HMC, you can rest assured that there are experts on hand to answer your questions and provide meticulous and dedicated support at all times. The jobs of a senior project manager that we have include:

● Develop a specific research plan to thoroughly manage and monitor each project, as well as monitor risk management

● Narrow down all research needs at the local level - including central labs, warehouses and other third parties (on request)

● Organize, plan and hold investigator meetings

● Continuous project status tracking, with comprehensive and transparent client reporting

● Negotiate budgets and execute contracts with research sites to provide the most cost-effective option.

● conduct initial and regular research group meetings, to ensure effective planning, organization, and conduct of research

● Manage all research related issues in all phases of the trial

Clinical Operation

1. STUDY START-UP

 With its expertise, HMC will help make your tests a success. We'll work out effective participant sign-up strategies, quick processes, and efficient venue selection to make your trial go as fast as possible with minimal to no complications.

 Our top criteria is to: save time and costs but still ensure efficiency in the workflow. With decades of working experience, HMC ensures the testing process always runs on and ahead of schedule, while minimizing any potential risks. Here is our system of focus points to give you an overview of your startup:

● Evidence-based feasibility

● Carefully evaluated and selected position

● Identify and evaluate potential bottlenecks to create effective risk reduction strategies

● Clinical trial validation and legal documentation

● Collect and review site management documents

● Procurement of regulatory and/or ethics committee approvals

● Organize and hold investigator meetings

● Website initialization and rapid audience recruitment

 2. CLINICAL MONITORING

Your test will be a great success under our CRA monitoring team. HMC's CRA experts are always available at the test site for monitoring, wherever it takes place. All activities follow ICH GCP process, research protocol, monitoring plan and client's expectations. We will continuously update information, reviews and support 24/7.

What we offer our partners:

● Visits start the site

● Frequent site monitoring visits

● Site management and easy access - including regular site contact via phone, email, etc.

● Monitor the query resolution process

● Website support during database locking

● Research observational visits

If you need more than the points listed above, HMC has a custom service that ensures a good fit. Contact us now.

 3. SITE MANAGEMENT

You need professional site management to make the trial process efficient and get results quickly.

 HMC's CRA is highly trained and available 24/7. We are adept at building long-term partnerships with investigators and supporting effective trial recruitment, as well as ensuring consistent data quality and consistency.

Resources and tools that HMC offers you during your studies are:

● Training and educating site staff

● Research of drug and non-drug supply logistics

● Keeping track of regulatory document revisions

● Monitoring protocol deviations

● Subject state tracking in trials

 4. SAFETY MONITORING

 Keeping patient safety and reducing risk should always be the first priority.

 In our staff development strategy, there are always safety and therapy areas and pieces of training. HMC medical monitors are available 24/7.

 In our staff development strategy, we provide safety areas as well as therapy options for our training. HMC medical monitors are available 24/7.

 Strategic services that HMC provides:

● Medical supervision planning

● Performance of medical surveillance inclusion/exclusion criteria

● Therapy area training for CRA and PM

● Assistance in SAE (Serious Adverse Event) reports to investigators

● Interaction with the Data Safety Monitoring Board (DSMB)

● Distribution of secure information reasonably among investigators

● Announce safety notice to regulatory authorities and/or ethics committee

 5. CLINICAL TRIAL LOGISTICS

To make your trial go smoothly, our clinical trial logistics will:

● Apply for import and export permits from regulatory agencies

● Prepare customs documents

● Import research products, comparators, and research materials, including laboratory kits and any specific equipment

● Store, distribute, relabel, return, and destroy investigative materials/equipment.

● Export biological samples from clinical sites to the central laboratory

● Management of courier services

With industry-leading experts and extensive relationships, we always support you wholeheartedly.

 6. VENDORS' MANAGEMENT

If you find it difficult to understand the risks, relationships, or other policies in connection with laboratories and warehouses, then simplify things by working with HMC. We have strong relationships with all parties: quality assurance, advanced technology, and full certifications. The associates of HMC have always been reputable in clinical trials and enthusiastic support at all times.

Data Management

Data management in clinical trials is a necessary step to ensure accurate and reliable data are obtained.

HMC's team of experts are always qualified to provide the following services:

● Participate in designs of Research Protocols to ensure that data is appropriately Collected and managed

● Develop Data Management Plans

● Develop CFR and EDC according to CDISC, SDTM, CDASH standards

● Performance of data validation activities, including: Project-specific Editing, Test Specifications, Data Validation Plan, automated test programming, input masking, and data review.

● Develop a Data Transfer Plan

● Data entry and CRF tracking for paper CRF

● User training for EDC system and CRF completion rules

● Load data from external sources (central lab, ECG, etc.)

● Integrate the drug delivery and randomization (IWRS) module directly into the EDC . system

● Quality control of imported data

● Data cleaning operations for temporary and final database locking

● Prepare data management reports for quality control and metrics measurement

● Medical coding using MeDRA, WHODD and SAE collation

Biostatics

Biostatistics in clinical research

You will always receive real and timely data. Using advanced tools and techniques, HMC provides strategic services:

● Design clinical study protocols, including statistical input

● Sample size calculation

● Create Statistical Analysis Plan (SAP)

● Develop analytical datasets, as well as tables, figures, and list templates (TFLs)

● Generate random diagrams

● Create drug labeling lists

● Statistical SAS programming

● Central data monitoring throughout the study

● Statistical data analysis

● Prepare mid-year and end-of-year statistical reports

● Analysis after the lesson

● CDISC mapping and transformation

Quality Assurance

With this service package, you can rest assured that your implementation and monitoring processes are always up to the highest international standards.

The HMC team will show you the most comprehensive and unbiased assessment of your ongoing processes, and offer valuable advice on how to maximize your potential, doubling your surplus and value test treatment.

Our managers can establish a plan to organize contract audits and provide a range of clinical trial consulting services.