Logo
 
Chat Here
Chat Here
Peer review
paper published
by GAP

Medical writing,
Clinical Expertise,
Technical Development
is our core
competency

Data Safety
Monitoring Board
(DSMB)

DSMB

Clinical
Events
Committee

CEC

Safety
Assessment
Committees

SAC

Message
from
the CEO

President
and
Co-founder

Our
Service
Card

Business
Card

Automated
Remote Data Manage
QC and Medical
Monitoring
Service

Business
Card

We wrote
the book
On
GPV & E

Pharmacovigilance
is
What We Do.

We wrote
the book
On
Immuno-Oncology

Oncology-Clinical
Devlopment
is
What We Do.

javascript


Clinical Affairs

We provide the key to your success.

With the proven track record in managing programs in all phases of clinical development; we are the key to your success. We have conducted many pivotal trials leading to FDA- EMEA and/or international regulatory approvals among multi-dimensional registers. NDA, BLA, 510K, and PMA development process have been our forte. We particularly support our clients in the late stage development approval process. Deploy our clinical team to assess your integrated ambitions. We will produce the shortest and the most effective strategies. That is our niche expertise.

Others claim to have pioneered the concept of "Contract Research Organization;" we claim to be the best. We have learned to strive for excellence via the following:

  1. We have attained an experienced team who understands pharmaceutical industry and the challenges that our sponsors face.
  2. Proven track record in gathering the best and the brightest in the world of medicine in every specific therapeutic area. Oncology is our pivotal/hinging expertise.
  3. Clinical trial services with the pronounced alignment in your scientific and cost parameters.
  4. The most competent and capable? Medical, regulatory, safety, data management, bio-statistics and clinical operations, as well as its leadership.
We provide services in the following core competencies:
  1. Phase I-IV/biomarkers studies
  2. Biostatistics
  3. Clinical/Trial Monitoring
  4. Data Management
  5. Patient & Investigator Recruitment
  6. Regulatory
  7. Safety/surveillance & Risk Management
  8. Medical Devices
  9. Therapeutic Expertise in Oncology