FAQs: Working as your Oncology CRO Partner
How to work with us as your full service oncology CRO
Phase Clinical Services is an agile oncology CRO, focused on the success of your clinical trials. Our approach to trial operations is designed to accelerate drug development. Because so much depends on operational issues, we draw on our extensive experience in clinical trial management. We welcome your questions at firstname.lastname@example.org.
Q1. How many hospitals are in your network right now?
Currently, there are 11 hospitals in our network. About half of the hospitals are oncology centers, the others are general hospitals with a strong oncology department.
Q2. How many patients do you have access to?
Currently, we have 50k+ oncology patients/year available in our network. See available patient numbers in our Patient Availability Calculator.
Q3. Have those sites conducted clinical trials before?
Yes, some of the PIs in our network are listed with ClinicalTrials.gov for past and ongoing trials.
Q4. With whom are you contracting?
We are contracting with a major local oncology network which has strong ties to the hospital sites and government offices.
Q5. Do your sites have electronic health records (EHR) in place?
EHRs are available in some hospitals and we are establishing searchable datasets to provide to sponsors. We are also planning to collect electronic patient data directly from physicians.
Q6. In which countries are your hospital sites?
We are currently covering a developing part of Southeast Asia. We are working towards expanding our hospital sites to include the U.S., South America, Australia, and Eastern Europe.
Q7. Why are you active in Southeast Asia? Why now?
While we are based in New York, we have partnered with many hospital sites in Southeast Asia. Several key factors are worth mentioning:
- There is a large patient population
- Oncology patient profiles differ somewhat from Western Countries in that they are often treatment-naïve, late-stage and focused on other cancers such as stomach and colon
- Local expertise to conduct clinical trials according to FDA and EMA standards is clearly present as well as advanced equipment and technology, but the market is not saturated yet as e.g. in the U.S. and the EU
- Patients can profit from cutting edge medications otherwise not available to them
- Doctors and hospitals are eager to participate in international research to improve their knowledge and enhance their reputation
- Funds from clinical trials can be used to improve overall healthcare for hospitals or whole countries
- High-quality trials can be conducted in a more timely and cost-effective way compared to Western countries
- Data from clinical trials in Southeast Asia is routinely accepted by the FDA, EMA and other authorities. International ethical standards are followed, e.g. by the International Conference on Harmonization – Good Clinical Practices (ICH-GCP). Also, FDA and EMA inspections data show less adverse findings compared to the U.S. or the EU, indicating high compliance to standards.
Q8. How long does it take to obtain IRB approval?
If the trial protocol follows internationally acceptable principles, approval is typically a matter of weeks when working through our network.
Q9. Do you cover different cities in a country?
Yes, we cover major cities as well as medium-sized cities.
Q10. Can your sites assess molecular biomarkers such as ALK, EGFR, KRAS?
For some hospitals, molecular biomarkers are assessed on-site. For others, biomarkers, are analyzed in the U.S. according to domestic standards in collaborations with fully accredited American labs. We are also registered with the CDC Import Permit Program to bring potentially infectious material safely into the U.S.
Q11. What does your IT infrastructure look like?
We are implementing top-quality clinical trial-related software solutions to match sponsor requirements, such as the CDISC Define-XML standard. This will ensure trial preparation, conduct, and data handling will be efficient, transparent and secure.
Q12. Are you offering patient data?
Our high-quality searchable patient datasets will be made available in a fully compliant way to allow sponsors for better study planning and conduct.
Q13. Can we employ Phase Clinical Services for only a certain part of clinical trials, such as patient recruitment?
Yes. While we are a full-service CRO, we are available for a la carte services.
Q14. Can you work together with other CROs?
Yes, we can partner with other oncology CRO companies to tackle specific parts of a clinical trial if necessary.
Q15. Where are you located?
We are headquartered in Mt. Kisco, New York and trials are managed from this location. The trials themselves are conducted overseas.
Phase Clinical Services has a local presence in the following regions:
Mt. Kisco, NY (HQ)
Philadelphia, PA (Mid-Atlantic)
Washington, DC (Mid-Atlantic)
Houston, TX (Southwest)
San Francisco, CA (West Coast)
Q16. Can you provide patients other than for cancer?
Yes, since about half of the hospitals in our network are general hospitals, we can set up custom projects for non-oncology indications such as for CNS, cardiovascular, allergies, etc.