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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 Division of Medical Education and Research (DMER) and is independent from the MakatiMed Institutional Review Board (IRB).
The Clinical Research Center (CRC), under the Division of Medical Education and Research, maintains a master list of all clinical trials conducted at MMC. To ensure an accurate list, all sponsors or investigators must accomplish the Clinical Trial Application Form (see attachment) and submits to CRC. CRC facilitates the initial submission of the study protocol and related documents to the Institutional Review Board (IRB).
CRC offers the following services:
I. Support for sponsor-initiated trials:
- Support for feasibility studies
- Start-up activities
- Resource Planning
- Study Budget Development
- Contract Management
- Document Management Support
- Support for First-Participant Visit
- Logistical Support for On-going Trials
II. Support for investigator-initiated trials:
- Research-related Trainings / Resources
- Referral for Study Grants
- Research Statistician Services
III. Research Compliance Review
CRC encourages doctors to allow the Center 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.
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 standard 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 Center for Regenerative Medicine depending on the availability of resources. These centers have phlebotomists who 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 Center for Regenerative Medicine. Fees apply for these services.
Sample Processing and Storage
Center for Regenerative Medicine, which is a unit of the Department of Pathology and Laboratories can process biological samples for your study according, package samples* and store samples according to your protocol. The department is equipped with biological safety cabinets, refrigerated centrifuges, and -20degrees C and -80 degrees C freezers.
*Packaging with proper labeling materials must be provided by the Sponsor.
Infusion of Investigational Products
Ambulatory infusion services are offered by the MakatiMed Cancer Center, the Center for Bone Health and Center for Regenerative Medicine . 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.
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.
Center for Regenerative Medicine
The Center for Regenerative Medicine 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 Center for Regenerative Medicine 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.
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.
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
Steps in Starting an Industry-Sponsored Clinical Trial at MMC | ||||||
Step 1 | Step 2 (2-3 weeks) | Step 3 (2-3 weeks) | ||||
Accomplishment of Clinical Research Application Form (CRAF) and Submission of Documentary Requirements | Resource Planning and Study Budget Development | Contract Management (contract review, negotiation, approval and release for execution) |