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From drugs to cell and gene therapies, Makati Medical Center can be your home for clinical research with the help of the Clinical Research Center.
 
CLINICAL RESEARCH CENTER (CRC)
Established in 2014, the Clinical Research Center offers an array of services to support clinical research, particularly clinical trials and other industry-sponsored studies. It is under the Medical Education and Research Division (MERD) and is independent from the MakatiMed Institutional Review Board (IRB).

The CRC’s goal is to help translate the study protocols of a doctor, an industry sponsor, or an industry collaborator into successful clinical studies by connecting them to resources within Makati Medical Center. The CRC also provides its expertise in human subject protection, preparation and management of contracts and budgets, patient-flow analysis and data collection planning.

The CRC’s services encompass any stage of the study, but emphasis is placed on planning. We encourage doctors to allow us to be part of their research plans, and for industry sponsors to contact the center even at the feasibility stages of their studies. All services provided by the CRC are at no cost to any doctor or industry sponsor. Residents and Fellows are encouraged to avail of our services early on.

Connecting with the CRC can improve a study’s chances of success in implementing protocols and shorten the lead time to initiate studies.
The CRC also provides Good Clinical Practice Training. Please contact the CRC to schedule a training.
 
SERVICES                                                                               
  • Support for feasibility studies
  • Start-up services including resource planning, patient-flow analysis, data collection planning & gathering of essential documents (ICH-GCP Section 8.2)
  • Budget planning and management for study-related hospital services
  • Initial contract or clinical trial agreement (CTA) review
  • Study account set-up
  • Support during first patient  visit
  • Support in managing Hospital Study Account with MakatiMed’s Finance Division
  • Locating study coordinators
  • One-day Good Clinical Practice training and workshop
  • Two-day Clinical Trial Administration training and workshop for hospital staff
  • Consultation on planning and starting Investigator-Initiated Research, including statistical analysis plan and sample size calculation 
 
 
MAKATIMED SERVICES FOR RESEARCH

Pharmacy Services
Investigational drug management is provided by the MakatiMed Pharmacy Services Department. Pharmacy Services has dedicated personnel that can manage investigational drugs, including randomization, accountability, and dispensing.

Compounding of cytotoxic drugs is done at the MakatiMed Cancer Center. Drugs that are part of the standards of care may be sourced by outpatients at MakatiMed’s outpatient pharmacy, MedExpress.

 
Phlebotomy and Pharmacokinetic (PK) sampling
Phlebotomy services are performed at the Department of Pathology and Laboratories, Cancer Center and Cellular Therapeutics Center depending on the availability of resources. These centers have phlebotomists that can perform protocol-specific extraction procedures for off-site testing including PK sampling. Multiple time-point PK sampling can be performed by phlebotomists at the Cellular Therapeutics Center. Fees apply for phlebotomy services.
 
Sample Processing and Storage
The MakatiMed Department of Pathology and Laboratories and Cellular Therapeutics Center can process blood and biopsy samples for your study according to the protocol, package samples* and store samples. Both units are equipped with biological safety cabinets, refrigerated centrifuges, and -20 degreeC and -80 degree C freezers. The Cellular Therapeutics Center has liquid nitrogen storage. Fees apply for sample processing and storage.
                                         
*Packaging with proper labeling materials must be provided.   

Infusion of Investigational Products
Ambulatory infusion services are offered by the MakatiMed Cancer Center, the Center for Bone Health and Cellular Therapeutics Center. These Centers are experienced in handling investigational drugs.
 
Nursing Services
Routine procedures in clinical trials performed by nurses can be availed at our service units. These routine procedures include:
  • Vital Signs
  • Blood Pressure
  • Weight
  • Point-of-Care testing
  • Drug administration and Dispensing (except infusion)
  • Diary Administration
  • Questionnaire Administration
  • Adverse event monitoring (excluding SAE reporting)
  • Informed consent support
  • Others
 
For more information about any of these services, please directly contact the CRC. Please note that CRC will ask to review your study manuals and protocols.
 
 
Hospital Centers for Clinical Trials
The CRC can connect Investigators to service units within MakatiMed for their clinical trials.

Monthly charges may apply. Contact the CRC for more details.
 
Cancer Center
The Cancer Center offers comprehensive services for oncology trials such as chemotherapy preparation and administration, and research nursing service. Consultation rooms and research room with storage facilities (limited basis), coordinator work stations, and a monitoring area are also available.

Cellular Therapeutics Center
The Cellular Therapeutics Center is a state-of-the art center for trials in cell therapies. The Center has performed autologous cell-based therapies for various conditions and is one the few Centers accredited by the Department of Health. It is equipped with ISO class 100 clean room laboratory to manufacture clinical-grade cellular products. All cultured products are continuously validated through in-house assessments of cell identity and purity using magnetic separators (CliniMACS®) to isolate the cell of interest, flow cytometry and gene expression analysis.

The Cellular Therapeutics Center also has services and facilities for non-oncology trials such as drug administration including infusion, research nursing services, consultation rooms, biological sample processing and storage, and storage facilities for study documents and materials (limited basis), and monitoring space.

Diabetes Care Center
The Diabetes Care Center has the services and facilities for diabetes trials, such as insulin administration, research nursing services, nutrition counseling, and consultation rooms. The Center can also service non-diabetes trials.

MMC HealthHub
The MMC HealthHub has services and facilities for clinical trials such as drug administration, nursing services, consultation rooms, and private rooms for admission.

Other Patient Services
  
To get an overview of all services at Makati Medical Center click here.

STARTING A CLINICAL TRIAL AT MAKATIMED
It takes six (6) weeks from the submission deadline for the Institutional Review Board (IRB) to release a response (i.e. approval, disapproval, or queries) of the review. The timeline to study approval may vary depending on the time the Investigator provides a response to any IRB queries. For more information on the IRB, click here.

The timeline for the Institution to sign the clinical trial agreement (CTA) is two (2) weeks from submission if there are no queries. The timeline of the initial review of the CRC on the CTA will be shortened if all queries are answered. MakatiMed requires a tripartite agreement for the CTA and payment of an Institutional Fee. There is currently no prescribed contract template. For more information on the CTA and the Institutional Fee, contact the IRB office.

Below is a pathway to starting a clinical trial at MakatiMed.